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Monday, October 17, 2022

Dems focused on abortion rights worry they’re losing independent women

 Democrats are facing headwinds with one of their most important voting blocs – independent women.  

A New York Times/Siena College poll released on Monday shows female independents favoring the GOP by 18 points, a sizable increase since September at a critical juncture before the midterms.   

The findings come as Republicans zero in on inflation under President Biden as their closing argument.

“At the end of the day, voters are paying more for everything from groceries to energy. When families are struggling to make ends meet, and are having to decide between heating and eating, they are going to vote for change,” Karoline Leavitt, the Republican House nominee challenging Rep. Chris Pappas (D-N.H.) in New Hampshire’s 1st Congressional District, told The Hill on Monday. 

Democrats have focused much of their campaign pitches on abortion rights after the Supreme Court decision overturning Roe v. Wade roiled up their base. 

But now the party is facing questions about that strategy. 

“Democrats have overplayed their hand so many times when it comes to these cultural issues,” said one national Republican operative. “[Women] can’t afford to think about one issue and we’re also smart enough to think about multiple issues.”  

Democrats saw abortion rights as a winning issue as GOP governors and state lawmakers moved to adopt more extreme measures. They pointed to independents as a group that could be won over.  

But the closing message on abortion was always a gamble, now perhaps more than ever with gas prices again rising and inflation proving to be stubborn. 

Leavitt and Pappas are in a virtual tie in a state where reproductive freedom is considered a signature issue. 

“The Biden agenda has been disastrous for Americans across the board,” said Leavitt, who argued “the most effective way to get our country back on track” is by halting “reckless spending” and giving Americans more “energy independence.” 

Not all Democrats are tossing aside the abortion rights first strategy, and some operatives on Monday dismissed the New York Times poll.  

“I have the same skepticism of this poll that I had of polling in 2016/2020, which is that it doesn’t seem to account for a wave of first-time voters who aren’t traditionally reached by pollsters,” said one Democratic strategist. “In 2016, those new voters were people Trump brought out. Now it’s voters activated by abortion.” 

Other Democrats are more concerned given the hardships piling up for many voters. The survey showed 44 percent of voters ranked inflation or the economy as their top issue. 

Sen. Bernie Sanders (I-Vt.) in an op-ed for The Guardian warned that while protecting abortion rights is critical, Democrats should focus on addressing voters’ immediate economic considerations first.

“As we enter the final weeks of the 2022 midterm elections, I am alarmed to hear the advice that many Democratic candidates are getting from establishment consultants and directors of well-funded Super PACs that the closing argument of Democrats should focus only on abortion,” Sanders wrote. 

That view is not confined to Sanders, who often touts an economic message above all else. Veteran Democratic strategists James Carville and David Axelrod, two moderates who worked for former presidents Obama and Clinton, also recently expressed skepticism about the Democratic strategy. 

Not too long ago, Biden said that the economy was “strong as hell.” Republicans have resurfaced that remark in opposition research campaigns to paint him as out of touch.  

Democratic groups have spent millions on their messaging and ground games in key states, hoping to get independents to vote for their party. American Bridge, a Democratic political action committee, says women remain one of the most “critical” voting blocs to keeping control of Congress. 

“Through our research, we know that this group cares about both the future of their reproductive rights AND the economy,” said Julie McClain Downey, who serves as the group’s vice president of strategic communications.  

“For the next few weeks, it’s critical that Democratic candidates and groups continue to talk to them about our accomplishments and plans on both, while also pointing out the fact that Republicans only continue to get most extreme, dangerous and obstructionist on everything,” she said.  

In high visibility battlegrounds, Democrats and Republicans alike have tried to balance abortion rights and the economy.  

In Pennsylvania, home to one of the closely watched Senate races of the cycle, Democratic nominee John Fetterman has homed in on abortion access in an effort to galvanize the base while attracting independent and moderate Republican voters.  

Fetterman has repeatedly attacked his GOP opponent, former television Dr. Mehmet Oz, for not being clear enough on whether he would sign onto Sen. Lindsey Graham’s (R-S.C.) proposed national ban on abortions 15 weeks into a pregnancy. Democrats say the issue stands to play well across Pennsylvania, particularly in the Philadelphia suburbs.  

“I’ve always thought it was going to end up turning at the end of the day to the economy and to people’s pocketbooks. Elections like this always do,” said TJ Rooney, the former chairman of Pennsylvania’s Democratic Party. “But the question was are all the things that [have] gone in our favor on the margins enough to account for the deficit.”  

Oz has made inroads in the polls in recent weeks as his campaign and national Republicans have focused increasingly on crime. A poll conducted by Emerson College and The Hill late last month showed Fetterman leading Oz by only two points, down from his four-point lead in August.  

“The economy and crime are too big to overlook right now,” the national Republican operative said.  

Republicans also accuse Democrats of oversimplifying the abortion issue in their campaign materials, saying that voters don’t buy it.  

“When you ask voters are they pro-life or pro-choice, if you stop right there, that’s not actually a fair analysis on the issue of actually where they are,” the operative said.

https://thehill.com/homenews/campaign/3693208-democrats-focused-on-abortion-rights-worry-theyre-losing-independent-women/

Boston University Creates COVID Strain With 80% Mortality In Mice

 Researchers at Boston University have created a new strain of Covid-19 that has an 80% kill rate in humanized mice

In an effort to research what makes Omicron so transmissible, the researchers cobbled the Omicron spike protein to the original strain of Covid-19. The resulting virus was five times more infectious than Omicron.

"The Omicron spike (S) protein, with an unusually large number of mutations, is considered the major driver of these phenotypes. We generated chimeric recombinant SARS-CoV-2 encoding the S gene of Omicron in the backbone of an ancestral SARS-CoV-2 isolate and compared this virus with the naturally circulating Omicron variant," reads the pre-print.

The new research, which has not been peer-reviewed, was conducted by a team from Boston and Florida.

"In...mice, while Omicron causes mild, non-fatal infection, the Omicron S-carrying virus inflicts severe disease with a mortality rate of 80 percent," the researchers wrote, adding that while the spike protein is responsible for infectivity, changes to other parts of its structure are responsible for its deadliness.

Researchers attached Omicron's spike to the original wildtype strain that first emerged in Wuhan at the start of the pandemic.

The researchers looked at how mice fared against the new hybrid strain compared to the original Omicron variant. -Daily Mail

The researchers also looked at the effect of different strains on human lung cells grown in the lab - which Covid latches on to before instructing healthy cells to make copies of itself. They found that the modified strain produces five times more viral particles than the original Omicron strain (which all the rodents survived).

This study provides important insights into Omicron pathogenicity. We show that spike, the single most mutated protein in Omicron, has an incomplete role in Omicron attenuation. In in vitro infection assays, the Omicron spike-bearing ancestral SARS-CoV-2 (Omi-S) exhibits much higher replication efficiency compared with Omicron. Similarly, in K18-hACE2 mice, Omi-S contrasts with non-fatal Omicron and causes a severe disease leading to around 80% mortality. This suggests that mutations outside of spike are major determinants of the attenuated pathogenicity of Omicron in K18-hACE2 mice. Further studies are needed to identify those mutations and decipher their mechanisms of action. -Biorxiv

According to the scientists, however, their chimeric virus is unlikely to be as deadly in humans as it was in the mice because the specific breed used in testing are more susceptible to severe Covid.

Last year we reported that 18 months before the pandemic, scientists in Wuhan, China submitted a proposal to release enhanced airborne coronaviruses into the wild in an effort to inoculate them against diseases that could have otherwise jumped to humans, according to The Telegraph, citing leaked grant proposals from 2018.

The bid was submitted by zoologist Peter Daszak of US-based EcoHealth Alliance, who was hoping to use genetic engineering to cobble "human-specific cleavage sites" onto bat Covid 'which would make it easier for the virus to enter human cells' - a method which would coincidentally answer a longstanding question among the scientific community as to how SARS-CoV-2 evolved to become so infectious to humans.

Daszak's proposal also included plans to commingle high-risk natural coronaviruses strains with more infectious, yet less deadly versions. His 'bat team' of researchers included Dr. Shi Zhengli from the Wuhan Institute of Virology, as well as US researchers from the University of North Carolina and the US Geological Survey National Wildlife Health Center.

Darpa refused the contract - saying "It is clear that the proposed project led by Peter Daszak could have put local communities at risk," while warning that Daszak hadn't fully considered the dangers involved in enhancing the virus via gain-of-function research, or by releasing a vaccine into the air.

https://www.zerohedge.com/covid-19/boston-university-engineers-sars-cov-2-chimera-80-mortality-rate-mice

Cano-CVS deal reported off

 

  • Cano Health Inc CANO shares plunged after reports that CVS Health Corp CVS has decided not to pursue an acquisition of Cano. 
  • Dealreporter was the first to report that CVS had decided against pursuing a deal with Cano Health, the report cited people familiar with the matter. 
  • The news comes just a few days after Humana Inc HUM and CVS Health showed interest in U.S. primary care provider.
  • Hedge fund Third Point LLC, which owns 6.4% of Cano, has been pushing the company to put itself up for sale as its stock price has tumbled since it went public last year via the SPAC transaction.

New CDC data shows a fast rise in several BA.5 sublineages

 Public health experts have warned of a new winter wave of COVID-19, and now the latest data from the CDC showed several fast-spreading variants that may drive such a trend.

The Omicron BA.5 variant's dominance among sequenced cases in the U.S. has been declining since late August. Though it remained responsible for nearly 68% of cases as of Oct. 15, that percentage was down from about 75% reported for the week ending on Oct. 8.

eanwhile, BA.5 sublineages -- BQ.1.1, BQ.1 and BF.7 variants -- experienced a speedy uptick.

The latest data from the CDC showed that BQ.1.1 and BQ.1 each accounted for 5.7% of sequenced cases in the U.S. (up from less than 1% in mid-September), while BF.7 was responsible for 5.3%.

In an interview with CBS News, Anthony Fauci, MD, chief medical adviser to President Biden, said, "When you get variants like that, you look at what their rate of increase is as a relative proportion of the variants, and this has a pretty troublesome doubling time."

New COVID cases in the U.S. continue on a downward trend, with a 7-day moving average of 37,808, according to the latest CDC data. And deaths are also trending down, with a 7-day moving average of 332.

However, in the U.K. -- which has served as a harbinger for what's to come in the U.S. throughout the pandemic -- new infections have begun to swing upward.

The uptick overseas comes as some medical professionals in the U.K. have taken to social media to express concern over a potential new increase in COVID-related blood clots as a result of new variants.

Though experts in the U.S. told MedPage Today that they have not yet observed such a trend stateside, they acknowledged that the impact of new variants, such as BQ.1.1, as well as the ongoing risk of blood clotting during and after COVID infection, are both areas to keep a close eye on.

MedPage Today previously reported on an Oct. 7 report from the U.K. Health Security Agency that noted the recent development of new sublineages there "has been rapid." Specifically, the report detailed that the sublineages "have varying Omicron backbones but some convergent receptor-binding domain (RBD) mutations ... which are likely to produce a degree of escape from current immunity in the U.K."

In his interview with CBS News, Fauci acknowledged that likelihood. "The bad news is that there's a new variant that's emerging and that has qualities or characteristics that could evade some of the interventions we have."

"But," Fauci further told the outlet, "the somewhat encouraging news is that it's a BA.5 sublineage, so there are almost certainly going to be some cross-protection that you can boost up."

https://www.medpagetoday.com/special-reports/features/101261

Californians get third chance to vote dialysis clinic rules

 For the third time in three elections, California voters are being asked to require changes to the operations of dialysis clinics that provide life-saving care to 80,000 people with kidney failure.

Proposition 29 on the November ballot would require a doctor, nurse practitioner or physicians’ assistant to be present during treatment at the state’s 600 outpatient dialysis facilities.

Dialysis clinic companies say that under the mandate, between two and three doctors would be required at every facility because most are open at least 16 hours a day, creating a financial burden that could lead some clinics to close.

Supporters insist that dialysis patients need more thorough care during their regular visits.

It’s the third consecutive general election where Californians have been asked to vote on dialysis regulations. It is one of the most expensive ballot questions in state history. Both sides have collectively spent more than $90 million this year, according to state records.

All three were backed by unions that represent health care workers. The two previous measures failed.

To stay alive, dialysis patients typically undergo four-hour treatments at least three times a week, during which the machines remove the blood in the patient’s body, filter toxins out, then put the blood back in, essentially temporarily performing the functions of the kidneys but outside the body.

DaVita Inc. and Fresenius Medical Care — two of the country’s largest for-profit dialysis providers — operate about three-quarters of the clinics in California.

Opponents of Prop. 29 say most clinics already offer high-quality care and are regulated by federal and state authorities. They also point out that all patients already have a nephrologist — a kidney specialist — who oversees their care and that nephrologists also direct each clinic in California. They say the initiatives are part of a tactic to pressure the dialysis companies to let workers unionize.

“This unnecessary requirement would cost hundreds of millions statewide, forcing dialysis clinics in California to cut back services or shut down, making it harder for patients to access their treatments — putting their lives at risk,” the No On 29 campaign said.

Supporters say it’s a question of safety.

“Most dialysis patients are medically fragile and often have other health issues,” said a statement from Yes On 29. “Currently, when serious problems occur most clinics just call 911, which puts patients at risk and contributes to ER overcrowding.”

In 2018, the union-backed Proposition 8 sought to cap dialysis clinics’ profits and force them to invest more of their profits in patient care. Voters rejected the measure but not before it became the most expensive initiative on the 2018 ballot, generating more than $130 million in campaign spending — more than $111 million from dialysis companies to kill the initiative and about $19 million from unions that supported it.

Two years later, voters rejected Proposition 23, which would have made mandates similar to this year’s measure.

https://apnews.com/article/health-elections-california-dialysis-government-and-politics-495dba6c77648eca36bea8fd8fa72eb2

FDA pushes to remove pregnancy drug, company pushes back

 The maker of the only U.S. drug intended to prevent premature births is making a last-ditch effort this week to keep its medication on the market, even as health regulators insist that it doesn’t work.

A Food and Drug Administration meeting that opened Monday comes more than two years after the agency declared the drug ineffective and called for its removal. Drugmaker Covis Pharma has challenged the agency’s conclusion, setting up the highly unusual three-day public hearing.

The meeting underscores the limits of FDA’s authority and the long, onerous process to remove a drug on the rare occasion when a company won’t do so voluntarily at the agency’s request.

The hearing will resemble a courtroom trial, with FDA staff and company scientists presenting arguments for and against the drug Makena, followed by a vote Wednesday by a panel of outside experts. FDA leaders will ultimately make the final decision whether to order a withdrawal.

About 10% of U.S. births come too early — before 37 weeks, raising the risk of serious health problems and even death in infants. Complicating the Makena debate is support from the leading U.S. obstetrics group to keep the decade-old drug available while more research is done.

“The need for an effective treatment for preterm birth is great,” the American College of Obstetricians and Gynecologists says. “Makena and its associated generics represent the only treatment currently available to obstetrician-gynecologists to help prevent this condition.”

But the FDA says existing data shows weekly injections of the drug don’t help prevent a repeat preterm birth.

“Based on the evidence shown today, Makena is not shown to be effective,” said FDA’s drug chief, Dr. Patrizia Cavazzoni, in opening remarks Monday. “Its benefit and risk profile is unfavorable and it should be withdrawn from the market.”

The dispute is likely to increase scrutiny of the agency’s so-called accelerated approval program, which allows drugs like Makena to launch based on promising early results while additional, usually larger, studies are conducted.

“Makena is being used as an example of the many different criticisms of this program,” said Rachel Sachs, a food and drug law specialist at Washington University of St. Louis. “That may not be fair to the other drugs, other diseases, other patients groups, but we’re forced to respond to the situation it presents.”

At its best, the accelerated approval program is credited with speeding the availability of breakthrough therapies for HIV and cancer. But in the last decade, the FDA has been increasingly criticized for failing to follow up on expedited drugs with incomplete or unconvincing confirmatory data, including a large number of expensive cancer medications on the market.

In recent years, the FDA’s cancer division has begun prodding companies to stop selling their drugs for uses granted under these so-called “dangling approvals.”

The FDA approved Makena in 2011 based on a small study suggesting it reduced rates of premature birth in women with a history of early deliveries. Makena consists of a synthetic version of the hormone progesterone, which helps the uterus grow and maintain a pregnancy. Women can start the shots after 16 weeks of pregnancy.

Accelerated approval was granted on the condition that Makena’s original developer, Hologic, conduct a follow-up study confirming the drug resulted in lower rates of disability and death among newborns.

But results from an international study of 1,700 women released in 2019 showed the drug neither reduced premature births — as originally thought — nor resulted in healthier outcomes for babies, while increasing the risk of blood clots, depression and other side effects in mothers.

In briefing documents released this month, the FDA said leaving Makena on the market “incurs false hopes, the risks associated with treatment, and other burdens” like excess medical spending. According to a recent federal report, the U.S. has spent $700 million on Makena since 2018 through various government programs, like Medicaid and Veterans Affairs.

The FDA opinion also applies to several generic versions of the shot.

Drugmaker Covis argues that Makena is effective and that flaws in the 2019 study obscured its benefit. The Luxembourg-based company points out that Black women are at higher risk for preterm birth, but made up just 7% of women in the international study, compared with 59% in the original U.S. study used for approval. It wants time to do another study in higher risk patients, particularly Black Americans.

A patient group set up with funding by Covis, the Preterm Birth Prevention Alliance, has made similar arguments in letters to the FDA.

“We believe there is no sound public health reason to deprive” patients and physicians of access to Makena, the company said in an emailed statement.

https://apnews.com/article/science-health-business-medication-premature-births-d257b0871a2a41668a97a6a83a0a7340

Biden thinks Fetterman is capable amid questions over his health

 The White House said on Monday that President Biden thinks Pennsylvania Democratic Senate candidate John Fetterman is capable amid questions over his health as he recovers from a stroke he suffered earlier this year.

“The president feels he is very much capable of doing the job,” press secretary Karine Jean-Pierre said.

She said Biden has had “many interactions” with Fetterman over the last several months as well as an in-person meeting in September. Biden is set to appear with Fetterman on Thursday at an event in Philadelphia.

“The president has found him to be an impressive individual who is just as capable as always,” Jean-Pierre said, adding that Fetterman, as lieutenant governor of Pennsylvania, is doing the job “with great ability.”

A NBC News interview last week raised fresh questions over Fetterman’s health when he used closed captioning to help him understand dialogue, answering questions orally after reading them on a computer screen. 

The effects of his stroke in May were discussed in the interview, which highlighted some of the difficulty Fetterman has in articulating himself. While it was common knowledge that Fetterman has been using closed captioning when talking to reporters since his stroke, the interview provided viewers with a look at his process and showed him struggling at times to find the correct word.

Fetterman’s health will be in the spotlight on Oct. 25 when he debates Republican Senate candidate Mehmet Oz.

https://thehill.com/homenews/administration/3692984-white-house-biden-thinks-fetterman-is-capable-amid-questions-over-his-health/