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Wednesday, January 18, 2023

Harris up, Biden and Buttigieg down in Democrat’s ‘iceberg’ primary

 According to Politico, Transportation Secretary Pete Buttigieg is easily withstanding Republican attacks on his rudderless tenure. But that’s not the real story. Champagne corks are popping in Vice President Kamala Harris’s office as Buttigieg’s problems appear to be wrecking his chances to replace President Biden on the 2024 Democratic ticket if Biden chooses not to run. 

Given the continuing obsession with everything Trump and the various circuses in the Republican Party, much of the establishment media and punditocracy are ignoring the shadow primary unfolding for the 2024 Democratic nomination. Like an iceberg, this primary is mostly under the surface. After all, jockeying to replace an incumbent president who harbors hopes of a second term is fraught with risk. 

Even in a weakened state, incumbent presidents are almost impossible to dislodge if they want to run for reelection. You must travel back to the 19th century to find a president shoved out of the way by his own political party. Even Lyndon Johnson could have retained the Democratic nomination in 1968 if he had been determined to keep it. It’s worth noting that Johnson still had the power to grab the nomination for his vice president, Hubert Humphrey, even though Humphrey did not contest a single primary. 

Incumbents are not kicked out; they choose not to run rather than face defeat. And every president wants to run for reelection. The idea that Joe Biden and his team would willingly hand the presidency to Kamala Harris, or anyone else, after four years was always ridiculous. As I wrote in 2021, “Biden and his loyalists did not spend the last 40 years slogging and scheming their way into power just to hand it over to a newcomer.” 

But Biden might not have a choice. His polling is weak, and the Dec. 20 YouGov poll had 54 percent opposing a Biden reelection run, compared to just 26 percent in favor. The discovery of top-secret records in his personal possession is not just a political embarrassment or potentially criminal; it helps Donald Trump wriggle off the hook for his own misconduct — an unforgivable sin among Democrats. Even the best excuse — that Biden doesn’t know what he’s doing — hardly helps. While not enough for Democrats to start abandoning ship, Biden’s documents blunder ends his brief post-midterm political honeymoon. 

Team Biden’s ‘Plan B’ takes a hit 

Even though Team Biden likely has always planned for reelection, they understand Biden’s precarious position as an 81-year-old hopeful with a history of verbal gaffes who won mostly because of who he wasn’t. There must be a “Plan B,” and in 2022 that “B” became Buttigieg. 

Nobody in the White House will ever admit it, but all the indirect evidence points to Team Biden trying out Buttigieg as a potential heir-apparent instead of Harris. As the midterm races started heating up and it looked like Republicans could be headed for a sweep, Secretary Pete mysteriously started showing up on the late-night talk shows and various Democrat-friendly news programs. The last time a transportation secretary had such a high profile was … never.

And Buttigieg was the only cabinet member raising his profile so aggressively. Members of a president’s cabinet do not just start showing up on the “Late Show” without the express approval of the president and his staff. Given Buttigieg is young, has been a candidate and performed creditably makes him a potential replacement. The fact of — and volume of — his appearances is the political equivalent of a smoking gun. 

And that smoking gun was pointed at Kamala Harris. 

Rumors have circulated about tension between Harris and Team Biden. Not only that, she was mostly nonexistent in the run-up to the midterms. Her weakened position opened the door for fellow Californian Gov. Gavin Newsom (D) to fire up his own not-so-subtle effort to raise his national profile. 

But it turns out being left with few responsibilities and kept in cold storage was a positive boon for Harris. On the coattails of his media tour, Buttigieg was hit with the Southwest Airlines meltdown and a major Federal Aviation Administration computer outage. And politically, Buttigieg cannot afford to spend time — though he must — digging out of that mess. While it is fair to say that Buttigieg had little control over either of those issues, the fact is that while politicians take credit for everything under the sun once he or she walks into office, the flipside is that you’re stuck taking the blame, too. 

Harris is the clear frontrunner for the Democratic nomination should Biden decline. She leads every credible challenger in every poll and most by double-digits (except a silly McLaughlin poll that includes Michelle Obama). Alternately, Buttigieg’s best poll was a December YouGov poll, with 14 percent, but he has mostly been stuck in the 10-11 percent range. He is barely ahead of Newsom or Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.) — with margins well within the polling margin of error. 

As a young up-and-comer, Secretary Pete maybe had an outside chance as potentially the first gay major-party nominee, with national electoral experience — he ran decently in the 2020 primaries, while Harris didn’t make it to Halloween.

But Harris checks more of the Democrats’ identity boxes. The very idea that a minority female vice president could be denied the Democratic nomination stretches credulity indeed. Harris is — and always was — the prohibitive favorite to be the next Democratic nominee not named Joe Biden. 

Looking forward to 2024, Kamala Harris is flying high, Joe Biden is losing altitude, and Pete Buttigieg is grounded.

Keith Naughton, Ph.D., is co-founder of Silent Majority Strategies, a public and regulatory affairs consulting firm. Naughton is a former Pennsylvania political campaign consultant. Follow him on Twitter @KNaughton711.

https://thehill.com/opinion/campaign/3817693-harris-up-biden-and-buttigieg-down-in-democrats-iceberg-primary/

Admin to 'target use of antipsychotics' in nursing homes

 The Biden administration is planning a crackdown to reduce the inappropriate use of antipsychotic medications in nursing homes and the misdiagnosis of schizophrenia in patients, the Centers for Medicare and Medicaid Services (CMS) announced Wednesday.

Beginning this month, CMS will conduct targeted audits to determine whether nursing homes are accurately assessing and coding individuals with a schizophrenia diagnosis, the agency said.

The initiative is part of a larger administration effort to improve the safety and quality of nursing home care, ensure adequate staffing levels and hold nursing homes accountable if they provide unsafe care.

There has been growing evidence from nursing home safety advocates that facilities inappropriately diagnose patients and overprescribe antipsychotic drugs as a way to sedate patients. 

“We have made significant progress in decreasing the inappropriate use of antipsychotic medications in nursing homes, but more needs to be done,” CMS Administrator Chiquita Brooks-LaSure said in a statement. “People in nursing homes deserve safe, high-quality care, and we are redoubling our oversight efforts to make sure that facilities are not prescribing unnecessary medications.”

Nursing home residents erroneously diagnosed with schizophrenia are at risk of poor care and prescribed inappropriate antipsychotic medications, CMS said. Antipsychotic medications are especially dangerous among the nursing home population due to their potential devastating side effects, including death.

The use of antipsychotic medications among nursing home residents is an indicator of nursing home quality and used in a nursing home’s Five-Star rating. But the rating excludes residents with schizophrenia, which gives an incentive to code residents as having the disease when they do not. 

“No nursing home resident should be improperly diagnosed with schizophrenia or given an inappropriate antipsychotic. The steps we are taking today will help prevent these errors and give families peace of mind,” Health and Human Services (HHS) Secretary Xavier Becerra said in a statement.

The federal government has been working to try to reduce the use of powerful antipsychotic medications — a type of psychotropic drug — among nursing home patients. 

A government watchdog report issued in November found about 80 percent of Medicare’s long-stay nursing home residents were prescribed a psychotropic drug from 2011 through 2019.

But despite efforts to reduce the use of antipsychotic medicines, the prescribing of another type of psychotropic drug — anti-seizure drugs — increased, likely in an effort to reduce regulatory scrutiny, the report from the HHS Office of Inspector General found. 

In addition, the report found the number of residents reported as having schizophrenia and those without a corresponding diagnosis increased 194 percent from 2015 to 2019, and was concentrated in relatively few nursing homes. 

In 2019, the unsupported reporting of schizophrenia was concentrated in 99 nursing homes in the country, which reported that 20 percent or more of their residents have the disorder.

The rating scores for nursing homes that have a pattern of inaccurately coding residents as having schizophrenia will be negatively impacted, CMS said.

https://thehill.com/policy/healthcare/3817773-biden-administration-to-target-use-of-antipsychotics-in-nursing-homes/

J&J Ends Large HIV Vaccine Trial in Latest Setback for Field

 Johnson & Johnson halted a big trial of its experimental HIV vaccine in the Americas and Europe, a disappointment for hopes of battling the global infectious disease after a similar form of the shot failed earlier in a study in Africa.

The Mosaico study ended early after an independent data and safety monitoring board found it didn’t significantly reduce the risk of HIV infection, the company said Wednesday in a statement. The study had been testing the vaccine, which exposes the immune system to HIV proteins via another harmless virus called adenovirus26, in 3,900 people.

https://www.bloomberg.com/news/articles/2023-01-18/j-j-jnj-ends-large-hiv-vaccine-trial-in-latest-setback-for-field

Aprinoia Goes Public Via Wilbur Ross-Backed SPAC, Joins Alzheimer's Race

 

  • Neurodegenerative diseases-focused Aprinoia Therapeutics has announced a business combination with Ross Acquisition Corp II 
    ROSS
    , a special-purpose acquisition company founded by former Commerce Secretary Wilbur Ross, at an equity value of $280 million
  • Wilbur Ross has personally invested $7.5 million through convertible notes and committed up to $12.5 million of capital infusion at the closing.
  • Aprinoia, founded in 2015, is a clinical-stage biotech company developing novel therapeutics and precision diagnostics for treating neurodegenerative diseases.
  • The company has collaborations with Biogen Inc 
    BIIB
     and Bristol Myers Squibb & Co's 
    BMY
     Celgene, which includes certain non-exclusive license agreements on its lead tau PET tracer, APN-1607. 
  • "Aprinoia's tau approach is potentially complementary to beta-Amyloid-based products like Lecanemab. We're encouraged by the progress made in this field over the last two years and believe we're partnering with APRINOIA at the right time to continue advancing this field," added Wilbur Ross, CEO of ROSS.
  • Recently, Biogen's second Alzheimer's disease treatment, Leqembi (lecanemab), scored FDA approval in patients with mild cognitive impairment or mild dementia stage of the disease.
  • Concurrently, Aprinoia has out-licensed the China rights of APN-1607 to a large pharmaceutical company, whereby such company licensee has executed a binding term sheet agreeing to lead the product through its current Phase 3 trial in AD and target 2024 for commercialization of APN-1607 in China.
  • The licensee has committed approximately $8 million and RMB 14 million as an upfront payment, milestone payments, and royalties.
  • Aprinoia will continue to lead the development of APN-1607 in other jurisdictions. 
  • APN-1607 is in a Phase 2 trial for Alzheimer's Disease and is preparing for a Phase 3 trial in Progressive Supranuclear Palsy in the U.S.

Pentagon Forced To Tap Unreported Ammo Stockpile In Israel To Support Ukraine

 The New York Times this week has detailed more of the desperate behind the scenes scramble of US and Western officials to keep up the steady supply of arms and ammo, especially artillery munitions (155mm shells), to Ukraine in order to beat back the Russian invasion. It's yet another significant acknowledgement of the Pentagon's own dwindling stockpiles as it now must tap heretofore not publicly disclosed stores in Israel...

"The Pentagon is tapping into a vast but little-known stockpile of American ammunition in Israel to help meet Ukraine’s dire need for artillery shells in the war with Russia, American and Israeli officials say," the Times reports. "The stockpile provides arms and ammunition for the Pentagon to use in Middle East conflicts. The United States has also allowed Israel to access the supplies in emergencies."

Western backers of Kiev are currently also seeking to prepare Ukraine to defend against an anticipated Russian spring offensive, and Ukrainian forces need hundreds of thousands of rounds. 

As for what's being tapped from the Pentagon's ammo stores in Israel, "About half of the 300,000 rounds destined for Ukraine have already been shipped to Europe and will eventually be delivered through Poland, Israeli and American officials said," according to the report.

The stockpile in Israel has previously gone unreported, while another stockpile held oversees is also being tapped, in South Korea. Both countries have themselves thus far maintained an official policy of not arming Ukraine, with Israel in particular coming under pressure by both Washington and Ukrainian officials to send lethal aid.

Israeli reluctance and the fact that it must walk a fine diplomatic line with Russia given the Russian military presence in Syria, makes the Pentagon using its Israeli stores for a conflict in eastern Europe deeply controversial. 

The new Tuesday NYT report continues a consistent theme which has been an issue concerning US defense officials since even the opening months of the war - how to arm Ukraine enough to claw back territory without endangering America's own defense preparedness.

The Times underscores this dilemma in the following: "The shipment of hundreds of thousands of artillery shells from the two stockpiles to help sustain Ukraine’s war effort is a story about the limits of America’s industrial base and the diplomatic sensitivities of two vital U.S. allies that have publicly committed not to send lethal military aid to Ukraine."

Last week, at a defense conference in D.C. some among the US Navy's top leadership put the dilemma in stark terms, with a reporter from Defense One capturing a top commander's words: "An admiral alluded to the US needing to choose between itself and Ukraine during a panel at the conference."

https://www.zerohedge.com/military/pentagon-forced-tap-unreported-ammo-stockpile-israel-support-ukraine

Avidity Fast Tracked for Treatment of Facioscapulohumeral Muscular Dystrophy

 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AOC 1020 for the treatment of facioscapulohumeral muscular dystrophy (FSHD). FSHD is a serious, rare, hereditary muscle-weakening condition marked by life-long, progressive loss of muscle function that causes significant pain, fatigue, and disability. AOC 1020 is being studied in the Phase 1/2 FORTITUDE clinical trial in adults with FSHD and is the company's second muscle-targeting small interfering RNA (siRNA) AOC in clinical development. Avidity plans to share data from a preliminary assessment of AOC 1020 in approximately half of study participants from the FORTITUDE trial in the first half of 2024.

https://finance.yahoo.com/news/avidity-biosciences-granted-fda-fast-140000349.html