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Monday, April 4, 2022

3 states sue over end of Title 42

 Three states on Monday sued the Biden administration over its plans to rescind Title 42, a Trump-era order that allows the U.S. to rapidly expel migrants who have crossed the border to seek asylum.

Missouri, Arizona and Louisiana filed the suit after the Biden administration on Friday announced it would lift the order on May 23.

The suit seeks to block the lifting of Title 42 by arguing the Centers for Disease Control and Prevention (CDC), which issued the order, violated the Administrative Procedures Act by failing to allow for a comment period on its revocation.

The CDC, however, didn’t use such notice and comment rulemaking to put the order in place, with the Trump administration instead using a sunset clause requiring the CDC to review the order every 60 days.

The bulk of the suit argues canceling Title 42 would cause a surge of immigration at the border that could overwhelm state and federal resources.

“Defendants’ unlawful termination of the Title 42 policy will induce a significant increase of illegal immigration into the United States, with many migrants asserting non-meritorious asylum claims,” the states write in their suit.

“The Termination Order will create an unprecedented surge at the border that will overwhelm Defendants’ capacity to enforce immigration laws at the border.”

The suit targets nearly every agency involved with either public health or the border, listing some 20 defendants, including agencies like the immigration court system that had little to do with the crafting or enforcement of Title 42.

The Department of Homeland Security (DHS) did not immediately respond to request for comment.

While crafted by the Trump administration just days into the pandemic, Title 42 has been used roughly 1.7 million times by the Biden administration, a figure that includes repeat crossers.

The Biden administration has said it plans to use numerous other avenues to swiftly remove those who cross the border, including another Trump-era policy, known as Remain in Mexico, which the White House has been forced to resume under court order.

“Once the Title 42 Order is no longer in place, DHS will process individuals encountered at the border pursuant to Title 8, which is the standard procedure we use to place individuals in removal proceedings,” Homeland Security Secretary Alejandro Mayorkas said in a statement Friday.


“Nonetheless, we know that smugglers will spread misinformation to take advantage of vulnerable migrants. Let me be clear: those unable to establish a legal basis to remain in the United States will be removed.”

https://thehill.com/latino/3258301-three-gop-states-sue-over-end-of-title-42/

People on Medicare can now get up to 8 free COVID-19 tests per month

 People on Medicare are now able to get up to eight free COVID-19 tests per month at participating pharmacies, the Biden administration announced Monday.  

The move comes after a similar initiative launched in January for people with private insurance, in response to the surge in demand for testing due to the surge in cases from the omicron variant over the winter.  

But people on Medicare were initially left out, leading to a push to figure out a way for tests to be free for them as well, especially given that seniors are among the groups most vulnerable to the virus.  

The new program goes into effect Monday. People on Medicare, including Medicare Advantage plans, will simply have to show their Medicare card at a participating pharmacy, and they can get the tests for free, with the pharmacy billing Medicare directly.  

Participating pharmacies include CVS, Walgreens, Walmart, Rite Aid and many major grocery chains. The full list is available here.  

The system for people on Medicare has fewer hurdles than people with private insurance face. Those with private insurance often have to pay upfront for their tests and then seek reimbursement from their insurer, a cumbersome process.  

The program is also a departure for Medicare, which does not usually cover over-the-counter tests. 

“For the first time in its history, Medicare is paying for an over-the-counter test,” said Meena Seshamani, deputy administrator of the Centers for Medicare and Medicaid Services. “This is because COVID-19 testing is a critical part of our pandemic response. Combined with the free over-the-counter tests available through covidtests.gov, this initiative will significantly increase testing access for Americans most vulnerable to COVID-19 and will provide valuable information for future payment policy supporting accessible, comprehensive, person-centered health care.” 

In addition, all Americans are eligible to have two sets of four tests mailed directly to their home through covidtests.gov.  

Demand for testing overall has fallen since its peak during the omicron surge as cases have fallen significantly. But there is a risk of a new increase as the more transmissible BA.2 subvariant of omicron circulates, leading experts to stress that maintaining testing capacity is key.  

https://thehill.com/policy/healthcare/3258174-people-on-medicare-can-now-get-up-to-8-free-covid-19-tests-per-month/

Senators announce $10 billion COVID-19 deal, leave out global aid

 Senators announced on Monday they had reached a deal to provide $10 billion for the fight against COVID-19, but the agreement leaves out funding for the global virus response. 

The agreement could clear the path for Congress to finally pass some new funding for the virus response, which the White House has been warning for weeks is urgently needed to allow it to purchase more vaccines, treatments and tests. 

The announcement comes after days of negotiations between a group of GOP senators and Senate Majority Leader Chuck Schumer (D-N.Y.), with negotiators signaling late last week that they were close to finalizing specifics. 

“From the beginning, Senate Republicans have insisted that any new requests from the Administration for COVID funding be paid for by repurposing existing funds. …Today’s agreement does just that by repurposing $10 billion to provide needed domestic COVID health response tools,” said Sen. Mitt Romney (R-Utah), who helped spearhead the deal. 

Schumer added that the deal will give the administration “urgently needed funding to purchase vaccines and therapeutics, maintain access to testing and accelerate the work on next generation vaccine research.” 

“This $10 billion COVID package will give the federal government – and our citizens – the tools we need to continue our economic recovery, keep schools open and keep American families safe,” Schumer added. 

The agreement will set off a scramble to try to clear the bill before lawmakers leave for a two-week recess by Friday. To get the deal through the Senate by then they will need buy in from all 100 senators, something that could be a significant lift. It would also need to pass the House, which is expected to vote on business-related coronavirusrelief this week.

The announcement comes after three sources told The Hill earlier Monday that negotiators had reached a deal for $10 billion in aid. The deal was first reported by The Washington Post

The deal will be paid for by repurposing previous coronavirus funding, a red line garnering at least 10 GOP votes for the bill. Those funds include redirecting money from a shuttered venues fund, transportation aviation money, a higher education emergency relief fund and a small business administration loans program. 

However, the $10 billion deal is less than half of the $22.5 billion the White House initially requested. Even that full amount was only for short-term needs, and the White House said it would need to come back for more money later. That means another COVID-19 funding fight could soon come down the pike. 

It’s also less than the $15.6 billion that was initially included in a government funding deal last month. The coronavirus aid was dropped out of the funding bill amid pushback from House Democrats who balked at using money previously greenlit for state and local governments to pay for the new coronavirus spending. 

That $15.6 billion included $5 billion for global vaccine efforts, but that was dropped from the final Senate deal over disagreements over how to pay for it. The Hill first reported last week that negotiators were going to drop the global spending.

he removal of $5 billion in funding for the global COVID-19 response is a major blow to efforts to vaccinate the world, which experts say is key to preventing dangerous new variants from forming and threatening the United States. Advocates and some Democratic lawmakers had pushed for significantly more than that amount, and are now set to end up with nothing amid the dispute over offsets. 

“Failing to fund the global fight against COVID-19 is a choice to extend the pandemic, to accept preventable suffering and insecurity for all, and to live with the knowledge that, deep in the time of the world’s greatest need, the United States gave up,” tweeted Peter Maybarduk, an advocate at the progressive group Public Citizen. 

Democrats had made a last-ditch effort to get at least $1 billion in global funding included in the $10 billion package but that ultimately fell short. Instead, Democrats quickly vowed that they will take up another bill later this year that could pair global coronavirus spending with Ukraine aid. 

“While we were unable to reach an agreement on international aid in this new agreement, many Democrats and Republicans are committed to pursuing a second supplemental later this spring,” Schumer said. 

“t is my intention for the Senate to consider a bipartisan International appropriations package that could include additional aid for Ukraine as well as funding to address COVID-19 and food insecurity globally. I urge Senators on both sides of the aisle to continue negotiating a global vaccines funding package,” he added. 

https://thehill.com/policy/healthcare/3258493-senators-reach-10-billion-covid-19-deal-leave-out-global-aid/

Sore throat, fatigue added to official NHS COVID symptoms list

 The United Kingdom’s National Health Service (NHS) updated its COVID-19 advice this week, adding nine new official symptoms of the virus, including sore throat, headache and fatigue.

The news comes as infection rates have been steadily rising in the United Kingdom (U.K.) and as the government winds down its free COVID-19 testing program. Only people deemed to be at serious risk of illness qualify for free tests starting this month.

In the U.S., the World Health Organization and the Centers for Disease Control and Prevention have already relied on the longer list of symptoms, but the U.K. body has listed just three symptoms for the past two years of the pandemic: high temperature, continuous cough, and loss of smell or taste.

The new full advisory from the NHS lists the following symptoms:

  • A high temperature or shivering (chills) — a high temperature means you feel hot to touch on your chest or back (you do not need to measure your temperature).
  • A new, continuous cough — this means coughing a lot for more than an hour or three or more coughing episodes in 24 hours.
  • A loss or change to your sense of smell or taste.
  • Shortness of breath.
  • Feeling tired or exhausted.
  • An aching body.
  • A headache.
  • A sore throat.
  • A blocked or runny nose.
  • Loss of appetite.
  • Diarrhea
  • Feeling sick or being sick.

“The symptoms are very similar to symptoms of other illnesses, such as colds and flu,” the new NSA advisory notes. 

British health experts have praised the latest move to expand the symptoms list after criticizing the shorter list in the past.

“We’ve been sharing the wider symptoms of COVID for almost 2 years because we were following the science, provided by the amazing ZOE contributors!” Tim Spector, lead scientist of the independent ZOE project, said on Twitter.

“NHS finally recognising that there are more -hopefully now people are aware it help bring down COVID numbers from record highs,” he added.

Spector is also a professor of genetic epidemiology at King’s College London.

More than 166,000 people have reportedly died in the U.K. of COVID-19 during the ongoing pandemic.  

https://thehill.com/policy/healthcare/3258522-sore-throat-fatigue-added-to-official-nhs-covid-symptoms-list/

Fauci's United Front Is Collapsing

 by Jeffrey Tucker via The Brownstone Institute,

Last week, medical journalist Katherine Eban posted at Vanity Fair the results of a long and detailed investigation into the lab-leak theory of the origins of SARS-CoV-2. The subject is moving ever more to the front-and-center of efforts to find out exactly what was going on at the highest levels in early 2020 that resulted in the greatest societal, political, and economic upheaval of our lives. 

How precisely did we move so quickly from the “germ games” of October 2019 – when the virus was already circulating in the US – to full-scale global lockdown by March? Why did Anthony Fauci, who in early February was downplaying the seriousness of the virus, flip to the other side (which we know from emails)? It was Fauci, according to many reporters, who tapped Deborah Birx to huddle with Trump and convince him that the only way to battle the virus was to “shut down” the economy – as if anything like that was possible much less effective for controlling a respiratory virus. 

For two years now, and despite endless writing and reflection, this change from the top has puzzled me. Lockdowns contradicted not only a century of public-health practice but even WHO guidelines. Even on March 2, 2020, 850 scientists signed a letter to the White House warning against lockdowns, closures, and travel restrictions. Within days, everything changed. 

There were hints of extreme measures in the CDC pandemic planning manuals since 2006 but the idea was hardly orthodoxy in the profession. It’s also true that there were elite scientists who longed for the chance to try out the new theory of virus suppression. But how did Fauci and Birx, to say nothing of Jared Kushner, become converts of the idea to the point that they were able to convince Trump to betray everything he believed in?

This is quite probably where the lab-leak theory comes in. It’s not so much about whether the virus was an accidental or even deliberate leak that matters so much as whether Fauci, Francis Collins, and Jeremy Farrrar of the UK’s Wellcome Trust believed it was possible or even likely. In that case, we have our motive. Did they deploy the chaos of lockdowns as a genuine if wildly misguided attempt to suppress the virus as a way of avoiding culpability? Or perhaps it was deployed as a kind of smokescreen to distract from a closer examination of the Wuhan’s lab’s funding sources? Or possibly there is a third reason. 

We have a very long way to go before the full truth is out. But Eban’s article adds tremendous detail about the great lengths to which our Fauci-led cabal of officials worked hard to suppress dissent on the question of lab-vs-natural origin. They kept papers from being posted on preprint servers, held Zoom sessions with authors in an attempt to intimidate them, and spent tremendous energy making it clear that there would be a no-leak “united front” no matter what. 

Writes Eban: “At the highest levels of the U.S. government, alarm was growing over the question of where the virus had originated and whether research performed at the WIV, and funded in part by U.S. taxpayers, had played some role in its emergence.”

Eban’s intrepid journalism now has former CDC director Robert Redfield opening up about how he not only warned about the possibility of a lab leak but also that he was then excluded from all strategy meetings thereafter. 

To Dr. Robert Redfield, the director of the CDC at the time, it seemed not only possible but likely that the virus had originated in a lab. “I personally felt it wasn’t biologically plausible that [SARS CoV-2] went from bats to humans through an [intermediate] animal and became one of the most infectious viruses to humans,” he told Vanity Fair. Neither the 2002 SARS virus nor the 2012 MERS virus had transmitted with such devastating efficiency from one person to another.

What had changed? The difference, Redfield believed, was the gain-of-function research that Shi and Baric had published in 2015, and that EcoHealth Alliance had helped to fund. They had established that it was possible to alter a SARS-like bat coronavirus so that it would infect human cells via a protein called the ACE2 receptor. Although their experiments had taken place in Baric’s well-secured laboratory in Chapel Hill, North Carolina, who was to say that the WIV had not continued the research on its own?

In mid-January of 2020, Vanity Fair can reveal, Redfield expressed his concerns in separate phone conversations with three scientific leaders: Fauci; Jeremy Farrar, the director of the U.K.’s Wellcome Trust; and Tedros Adhanom Ghebreyesus, director general of the World Health Organization (WHO). Redfield’s message, he says, was simple: “We had to take the lab-leak hypothesis with extreme seriousness.”

In sessions from which Redfield was excluded from early February, Fauci’s chosen participants strategized a statement published in the form of a medical paper: “The proximal origin of SARS-CoV-2.” The publication date was March 17, 2020, the day following Trump’s lockdown press conference. The paper was in fact written as early as February 4. Eban makes the salient point: “How they arrived at such certainty within four days remains unclear.” 

[Redfield] concluded there’d been a concerted effort not just to suppress the lab-leak theory but to manufacture the appearance of a scientific consensus in favor of a natural origin. “They made a decision, almost a P.R. decision, that they were going to push one point of view only” and suppress rigorous debate, said Redfield. “They argued they did it in defense of science, but it was antithetical to science.”

Two weeks following the drafting of the paper, “in a letter published in the influential medical journal the Lancet, [Peter Dazsak of EcoHealth, which had funneled US money to the Wuhan lab] joined 26 scientists in asserting, ‘We stand together to strongly condemn conspiracy theories suggesting that COVID-19 does not have a natural origin.’

A conspiracy theory!

We know for sure that those never turn out to be true!

Surely there was no such thing as a powerful cabal plotting to force a single orthodoxy on science in order to protect themselves from too much investigation into their own role in funding gain-of-function research! Except that this appears to be exactly what was happening. 

This strategy of information suppression and intimidation of dissent, along with the manufacturing of a fake consensus that in fact did not exist, continued through 2020 and arguably to the present. Among the other victims of such propaganda and smears were the authors of the Great Barrington Declaration. We know from emails that Fauci and Collins collaborated in a deliberate attempt to drum up a “quick and devastating” takedown. 

It was a rather bizarre thing to do. The GBD was a rather conventional statement of public health principles along with a warning against the devastating consequences of extreme measures of coercion. Today it reads almost like a summary of what most people have come to believe after long and terrible experiences. Why did the Fauci cabal believe it was so very important to stop this statement?

What we need now is a clearer linkage behind the now-documented attempt to forge a single narrative on the lab leak question and the decision to forge a single narrative about the need to lock down, and thus overthrow a century of public-health practice. What was the motivation here? What were they discussing in private in those crucial weeks in February 2020 leading up to the disaster? 

What is unbearably clear at this point is that this gang’s obsession with covering up a possible lab leak, in the interest of keeping their own fingerprints off the deed, completely distracted the leadership of the National Institutes of Health from what it was supposed to be doing at the time. And what was that? It’s not complicated. If you have a new pathogen sweeping a country, you want to focus on ways to keep vulnerable populations safe (for example, not forcing nursing homes to admit Covid-infected people) and discovering the best therapeutics to minimize severity for the general population.

This is not what happened. Instead, we had a plot against the US president, the deliberate cultivation of mass panic, forced closures of schools and businesses, wild demands for mass human separation, travel restrictions, ineffective mask and vaccine mandates, and the general triumph of crank science over experience, at the great cost of human liberties and rights and hence social and economic well-being. 

The reason for the chaos appears, in part, that during those crucial early months, public-health leadership in the US had another private agenda centered not on health but their own reputations and professional standing. Two years later, we live with the devastating consequences that have affected the whole of our lives. 

https://www.zerohedge.com/political/faucis-united-front-collapsing

Theravance Phase 3 in Orthostatic Hypotension Misses 2nd Time

 Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced results from the second Phase 3 study, Study 0170 (n=128 out of n=154 planned), assessing the durability of clinical effect of ampreloxetine compared to placebo for the treatment of symptomatic nOH. Study 0170 was a 22-week Phase 3 study comprised of a 16-week open-label period followed by a 6-week double-blind, placebo-controlled, randomized withdrawal period. The primary endpoint of treatment failure at week 6 of the randomized withdrawal period was defined as a worsening of both Orthostatic Hypotension Symptom Assessment Scale (OHSA) question #1 and Patient Global Impression of Severity (PGI-S) scores by 1.0 point.

The primary endpoint was not statistically significant for the overall population of patients which included patients with Parkinson's disease (PD), pure autonomic failure (PAF) and MSA (odds ratio=0.6; p-value=0.196). The odds ratio suggests that patients receiving ampreloxetine had a 40% reduction in the odds of treatment failure compared to placebo.

The pre-specified subgroup analysis by disease type suggests the benefit seen in patients receiving ampreloxetine was largely driven by MSA patients (n=40). An odds ratio of 0.28 (95% CI: 0.05, 1.22) was observed in MSA patients indicating a 72% reduction in the odds of treatment failure with ampreloxetine compared to placebo. The benefit to MSA patients was observed in multiple endpoints including OHSA composite, Orthostatic Hypotension Daily Activities Scale (OHDAS) composite, Orthostatic Hypotension Questionnaire (OHQ) composite and OHSA #1 (see figure below). Notably, patients withdrawn to placebo had a clinically relevant decrease in standing blood pressure; there was no decrease for patients remaining on ampreloxetine. While the same benefit was not apparent in patients with PD or PAF, the Company continues to analyze the data to better understand this observation. Throughout the study, there was no indication of worsening of supine hypertension based on 24-hour monitoring. Data suggest that ampreloxetine was well-tolerated and no new safety signals were identified.


CymaBay Publishes on Phase 2 Study of Seladelpar in Primary Biliary Cholangitis

 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced that results from the Phase 2, 52-week study of seladelpar in patients with primary biliary cholangitis (PBC) have been published in the Journal of Hepatology:

Bowlus CL, Galambos MR, Aspinall RJ, Hirschfield GM, Jones DEJ, Dörffel Y, Gordon SC, Harrison SA, Kremer AE, Mayo MJ, Thuluvath PJ, Levy C, Swain MG, Neff GW, Sheridan DA, Stanca CM, Berg CP, Goel A, Shiffman ML, Vierling JM, Boudes P, Steinberg A, Choi YJ, McWherter CA, A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis, Journal of Hepatology (2022), doi: https://doi.org/10.1016/j.jhep.2022.02.033.

This 52-week, phase 2, dose-ranging, open-label study examined the efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-delta agonist, in adults with PBC who were receiving or intolerant to first-line therapy with ursodeoxycholic acid. Eligible patients were enrolled with a minimum serum alkaline phosphatase (ALP) levels of 1.67 times the upper-limit-of-normal (194 U/L) and which were on average in excess of 318 U/L. Seladelpar was administered orally once daily at 2 mg (n=11), 5 mg (n=53) or 10 mg (n=55) for 12 weeks, after which doses could be increased up to 10 mg if needed to improve treatment response. Cirrhosis was present in 21% of patients; 71% had pruritus.

An interim primary efficacy analysis of ALP change from baseline at Week 8 found that seladelpar treatment provided 26%, 33%, and 41% reductions for the 2 mg, 5 mg and 10 mg doses, respectively (all p<0.005). Responses were maintained or improved at Week 52 which included dose escalation in 91% and 80% of the 2 mg and 5 mg cohorts, respectively. At Week 52, the composite biochemical response (ALP <1.67×ULN, ≥15% ALP decrease from baseline, and normal total bilirubin) rates were 64%, 53%, and 67%, and ALP normalization rates were 9%, 13%, and 33% in the 2 mg, 5 mg, and 10 mg cohorts, respectively. The pruritus visual analog scale score was also decreased in the 5 mg and 10 mg cohorts. There were no treatment-related serious adverse events (AEs), and 4 patients discontinued due to AEs.