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Thursday, February 2, 2023

Gilead profit beats Street expectations on COVID and HIV sales

Gilead Sciences Inc on Thursday reported a higher-than-expected fourth-quarter profit driven by strong demand for its HIV and cancer drugs, while COVID-19 antiviral Veklury had sales that were double Wall Street estimates.

The U.S. biotech company said adjusted profit rose to $1.67 per share, ahead of analyst expectations of $1.50, according to Refinitiv data, and up from 69 cents per share a year earlier, when it took $1.85 billion in charges mostly for a legal settlement.

Quarterly revenue rose 2% to $7.4 billion, topping analysts' estimates of $6.64 billion.

It forecast 2023 sales of $26 billion to $26.5 billion, ahead of analyst expectations of $25.8 billion, and adjusted earnings of $6.60 to $7 per share. The midpoint of the earnings forecast is also above analysts' estimates for $6.73 per share.

Sales of COVID-19 treatment remdesivir, sold under the brand name Veklury, were $1 billion, far beyond the $511 million analysts had expected even as they slowed 26% from the previous year.

While Veklury sales declined by about half in the United States and Europe as COVID hospitalization rates fell, they tripled in other international markets.

Gilead's HIV sales increased 5% to $4.8 billion in the quarter, with Biktarvy rising 15% to $2.9 billion versus the $2.8 billion analysts expected.

Descovy sales rose 13% to $537 million, outstripping the analysts' forecast of $495 million.

Gilead's cancer franchise also saw sales increase by 71% to $419 million. Yescarta, a CAR-T lymphoma treatment, booked $337 million, while leukemia and lymphoma treatment Tecartus came in at $82 million.

New Blood Pressure Target in Primary Care

 I'm Dr Neil Skolnik. Today we are going to talk about the new Blood Pressure Targets in Adults With Hypertension: A Clinical Practice Guideline From the AAFP (American Academy of Family Physicians). There are very few things that we treat more often than hypertension, so you'd think the guidelines would have been clear a long time ago. Less than 10 years ago, in 2014, JNC 8 recommended target blood pressure (BP) for individuals under 60 to be < 140/90, and for those older than 60, < 150/90.

Then, based primarily on the SPRINT trial (which included only people with or at significantly elevated risk for atherosclerotic cardiovascular disease), in 2017 the American Heart Association's hypertension guidelines lowered the target BP to < 130/80 for most individuals. It's a little more nuanced than that, but most of us don't remember the nuance. I've written about my reservations with that statement in the AHA's journal, Circulation.

Now the AAFP has updated its recommendations and they recommend a BP < 140/90. This is not a small change, as it often takes additional medication to achieve lower BP targets, and additional medicines lead to additional adverse effects. I'm going share with you some details from the new guideline, and then I'm going share my opinion about it.

The AAFP guideline applies to adults with hypertension, with or without cardiovascular disease. In the comprehensive literature review, the trials ran for an average of 3.7 years, and about 75% of the patients in the trials did not have preexisting cardiovascular disease.

The key to their recommendations is that target BPs lower than 140/90 did not show a statistically significant decrease in total mortality. In regard to serious adverse events, though, lower targets led to a nominal increase that didn't reach statistical significance. Serious adverse events were defined as death or events that required hospitalization or resulted in significant disability. In regard to all other adverse events, including syncope and hypotension, there was a significant increase, with a relative risk of 1.44 (a 44% increase in adverse events). This reflected an absolute risk increase of 3% compared with the standard target group (specifically 9.8% vs 6.8%), with a number needed to harm of 33 over 3.7 years.

Another potential harm of low BP targets was the need for an average of one additional medicine to reach lower BP targets. One systematic review cited an eightfold higher withdrawal rate due to adverse events in the lower target BP groups.

The AAFP guidelines said that in the comprehensive review of the literature, while there was no difference in mortality or stroke with lower BP targets, a small additional benefit was observed in myocardial infarction — a 16% lower incidence, with a number needed to treat of 137 over 3.7 years.

So that's the background. Let me now go over the specifics of the AAFP recommendations.

AAFP gives a strong recommendation for a standard BP target of < 140/90. They go on to say — and grading this next statement as a weak recommendation — that while treating to a lower BP target does not provide additional mortality benefit, a target BP of < 135/85 can be considered to lower the risk for MI, noting that lower BP may increase harms. They state that the lower BP target could be considered based on patient preferences and values.

The AAFP guideline is incredibly helpful. The difference in the recommendations of two large societies — American Heart Association (AHA) and AAFP — stems from two things. I believe that AHA focused on the composite endpoints in trials such as SPRINT, which only included high-risk patients, and the AAFP uses mortality as the driving endpoint in a broader group of patients that included both high- and lower-risk patients.

In addition, it appears that the two organizations weigh adverse events differently in coming to their conclusions. Clearly, we see more adverse events when aiming for a lower BP level, and in my experience, patients care a lot about adverse events.

Interestingly, the International Society of Hypertension recommends an "essential" BP target of < 140/90 for most individuals, and for those under 65, they provide the option of an "optimal" BP of < 130/80. Remember that for certain comorbidities, there are also other guidelines out there. The American Diabetes Association this year revised its target BP to < 130/80 for people with diabetes; for prevention of recurrent stroke, guidelines from the AHA/American Stroke Association in 2021 recommend BP < 130/80, and the International Society for Hypertension as well as the AHA recommends a BP of < 130/80 for those with established atherosclerotic cardiovascular disease.

To repeat, though, the main topic for today is that as a general target, the AAFP guidelines recommend a BP < 140/90.

Neil Skolnik is Professor, Department of Family Medicine, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia; Associate Director, Department of Family Medicine, Abington Jefferson Health, Abington, Pennsylvania

Disclosure: Neil Skolnik, MD, has disclosed the following relevant financial relationships:
Serve(d) on the advisory board for: AstraZeneca; Teva; Eli Lilly and Company; Boehringer Ingelheim; Sanofi; Sanofi Pasteur; GlaxoSmithKline; Merck; Bayer
Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Boehringer Ingelheim; Eli Lilly and Company; GlaxoSmithKline
Received research grant from: Sanofi; AstraZeneca; Boehringer Ingelheim; GlaxoSmithKline; Bayer
Received income in an amount equal to or greater than $250 from: AstraZeneca; Teva; Eli Lilly and Company; Boehringer Ingelheim; Sanofi; Sanofi Pasteur; GlaxoSmithKline; Merck; Bayer

Florida's workforce is larger than New York's for first time

 Florida's economic boom has pushed the Sunshine State above New York in the number of employed workers for the first time.

According to data released this week by the Bureau of Labor Statistics (BLS) for the month of December 2022, Florida had 9.669 million employed workers compared to New York's 9.661 million. That marked the first time since the BLS began using this data set in 1982 that Florida's workforce was larger than New York's.

A spokesman for Florida Gov. Ron DeSantis (R) told FOX Business, "As Governor DeSantis said in his second inaugural speech, 'It is often said that our federalist constitutional system – with fifty states able to pursue their own unique policies – represents a laboratory of democracy.' Florida has exemplified the successful example of freedom, and our success is revealed in metrics like this."

The spokesman also pointed to data indicating that Florida has led the country in new business formations with over 1.7 million created since January 2020 and that over one-third of those were launched in 2022 alone.

In early 2020 prior to the onset of the COVID-19 pandemic, New York had about 9.8 million jobs to Florida's 9.1 million jobs based on BLS data. 

The two states' workforces were roughly equal in size from April to July 2020 while both were recovering jobs lost during the initial economic contraction due to pandemic restrictions.

By the fall of 2020, New York had recovered enough jobs to open a roughly 300,000 job gap between it and Florida. 

But Florida began to narrow that gap to about 200,000 jobs by the start of 2021, and to 100,000 for most of 2022. By December 2022, Florida surpassed the Empire State for the first time ever – albeit by a relatively narrow margin of roughly 8,000 jobs.

Last year also marked another milestone for Florida, as it reached 9.2 million jobs and the state's labor force was larger than it was prior to the pandemic. For comparison, New York's labor force was about 200,000 jobs below its pre-pandemic level in the December data from the BLS.

Florida's economic growth has been driven by an influx of new residents who have moved to the state in the past year. 

Data released by the Census Bureau in December showed that Florida was America's fastest-growing state for the first time since 1957. 

Florida's population grew by 416,754 residents, or 1.9%, from 2021 to 2022 to more than 22.2 million.

New York had the largest population decrease of all 50 states from 2021 to 2022, as it declined by 180,341 residents, or -0.9%, to about 19.6 million.

Nearly Half Of Chicago Public School Students Chronically Absent In 2022

 by Hannah Max via,

Chronic absenteeism rates are higher in Chicago than statewide, with 49% of low-income Chicago students missing at least 10% of their days in school. That rate has nearly doubled since the pandemic.

Chronic absenteeism in Chicago Public Schools is on the rise: nearly 45% in 2022, according to state data. That compares to a statewide rate of 30%.

The rate is even higher among Chicago’s low-income students, with 49% missing at least 10% of their schooling, according to Illinois State Board of Education data.

The pandemic and 17 months out of the classroom appear to have seriously aggravated the problem.

Absenteeism in CPS was 24% for all students and just over 25% for low-income students in 2019. That was the final full school year before the pandemic shut down in-person learning in CPS schools.

But those numbers may not show the severity of the absentee issue in CPS. A recent report by the Chicago Board of Education Inspector General shows administrators in CPS may have misreported absent students as transfers, boosting attendance rates and other key metrics.

Chronic absenteeism among Chicago’s low-income students

The Board of Education reported 49% of low-income students in Chicago Public Schools were chronically absent during the 2021-2022 school year. Chronic absenteeism is determined by missing 10% or more of school days per year either with or without a valid excuse. That means nearly half of Chicago students from low-income families missed 18 or more days of school.

Research shows frequent absences from school place children and adolescents at a higher risk of poor outcomes, such as dropping out of school and lower academic achievement. Experts also find lower socioeconomic status is associated with higher levels of absenteeism.

Amid high rates of absenteeism, students from low-income families in CPS are struggling to meet proficiency in core subjects. Just 14% of 3rd through 8th grade students from low-income families met proficiency standards in reading and 9% in math this spring. Compared to students who are not from low-income families, low-income students were 28 percentage points less likely to score as proficient in reading and 27 percentage points less likely in math.

Missing school certainly can’t help.

It may be worse than the numbers show

While CPS absenteeism rates are already high, the data may be worse than reported because of miscoding of students as transfers rather than truant.

The CPS Inspector General’s 2022 annual report released in early January 2023 questioned the reliability of CPS’s transfer and dropout data, which is used to calculate metrics such as attendance rates. The investigation found “a districtwide problem of schools failing to document transfers and lost children as required by law and CPS policy.”

This misreporting of students is not new to CPS. The Office of the Inspector General has investigated and reported on this kind of misconduct five times since 2014, according to the report.

The report concludes the consequence of this misreporting is twofold: it causes significant negative effects on vulnerable students and produces unreliable CPS metrics.

CPS has procedures in place to locate and reengage missing students. Students whose absenteeism is hidden by administrators do not receive those interventions and the reengagement assistance they need and would otherwise have received if they were properly reported.

The district’s key metrics, such as attendance and graduation rates, may be skewed by misreporting.

CPS student attendance isn’t helped by the frequent Chicago Teachers Union walkouts

The militant bargaining tactics used too often by Chicago Teachers Union leaders to get their demands met have not been in the best interests of CPS students and families. They have left district students missing even more days of classroom instruction. CTU has walked out on students five times since 2012, with students missing at least 24 days of school as a result.

It’s probably hard for students to take school seriously when CTU walks out at a moment’s notice.

CPS is committed to improving student attendance

The Illinois Policy Institute contacted CPS for comment about the district’s low rates of absenteeism.

The district responded that it is committed to improving and expanding methods which work to help students return and stay in the classroom. CPS has made additional investments during the 2022-2023 school year since COVID-19 impacted student attendance in districts across the country. Investments include targeted interventions, additional systems of support, mental health services and other support services.

See the entire response from Chicago Public Schools about chronic absenteeism.

Hunter Biden $55,000 Offer For Russian Oligarch Info Falls Under Fresh Scrutiny

 An email from Hunter Biden to US aluminum company Alcoa is raising fresh concerns over the first son's access to classified documents which were recently discovered in his father's home in Wilmington, Delaware, as House Republicans kick off investigations into allegations of influence peddling.

The emails which date back to 2011 reveal Hunter Biden offering to trade information on Russian oligarchto Alcoa for $55,000, according to the NY Post's original October 2021 report.

Specifically, Hunter - while his father was Vice President - offered to provide a "statistical analysis of political and corporate risks, elite networks associated with Oleg Deripaska, the Russian CEO of Basic Element company and United company RUSAL."

Deripaska had notably just signed a metal supply agreement with Alcoa - which Hunter also offered a "list of elites of similar rank in Russia, map of [Deripaska’s] networks based on frequency of interaction with selected elites and countries."

Oleg Deripaska

Now, in light of the fact that classified documents have been found all over the house that Hunter was living at, the Alcoa revelation raises new questions over Hunter's access to sensitive information.

The deeply detailed proposal has come under sharp scrutiny given recent revelations that Hunter Biden had access to the Delaware lake-front home where secret papers from his father’s time as vice president were discovered in a garage, basement and library — combined with Republicans taking control of the House of Representatives.

Rep. Jim Banks (R-Ind.), the high-profile former chairman of the conservative Republican Study Committee, told The Post that the Alcoa solicitation fits within a broader picture. -NY Post

"The Biden family is the most corrupt family in the history of American politics," said Banks. "The biggest question facing Republican investigators: Where to begin?"

Sen. Ron Johnson (R-WI) has also raised the question over whether Hunter used classified documents found at the 6,850 sqft mansion in his business dealings.

Specifically, Johnson referenced an April 12, 2014 email from Hunter to his business partners about Ukraine, which looked "suspiciously" like it could have contained classified information.

"It reads like one of those scene-setters — highly detailed information in terms of Ukraine," Johnson told Fox News on Tuesday.

The email, from Hunter to partner Devon Archer, includes a 22-point memo which he described as "thoughts after doing some research." It included predictions such as the election of former Ukrainian President Petro Poroshenko, as well as "some sort of decentralization will likely occur in the East."

"If it doesn’t the Russians will continue to escalate there [sic] destabilization campaign, which could lead to a full scale take over of the eastern region most critically Donetsk," Hunter wrote. "The strategic value is to create a land bridge for RU[ssia] to Crimea."

Next week kicks off fresh hearings in the House Oversight Committee, which will investigate Hunter's alleged influence peddling - including cashing in on his ties to his father in order to rake in millions from foreign companies.

"We have evidence that … we’ll continue to be transparent with as we start our hearings next week, where this family is taking in millions of millions of dollars from our adversaries," said Rep. James Comer (R-KY), Chairman of the committee. "And I think we need to determine what was that money for [and] who supplied that money?"

"Why did the FBI, according to Elon Musk and the Twitter Files … the FBI was implying to them that that laptop was Russian disinformation," Comer continued. "It’s not, and what’s concerning is the FBI had the laptop. Why were they doing that?"

"The New York Post is fourth biggest newspaper in America; they’re a credible news organization. They’ve done extensive reporting on on the hard drive," Comer said, adding that the committee must dispel "a lot of misconceptions about the laptop."

"So we’re gonna start with with the hard drive, because there’s a lot of evidence on the hard drive that would suggest that Joe Biden knew very well what his family was involved in."

"There’s emails from some of these people’s texting and emailing Hunter Biden saying, ‘Thanks for setting up the meeting with your dad. This is why we’re investigating – we want to make sure that our national security is not compromised," Comer continued, adding that Hunter's international business dealings are particularly suspicious given the services he was providing to foreign agencies.

"We’d like to know what that consulting was. I feel like if China or anyone pays you millions of dollars they expect to get a return on that investment," said Comer. "If they would explain that, then think that a lot of these problems would subside a little bit, but all they do is just like roll their eyes or the audacity of Republicans to ask these questions."

The oversight committee has pressed Treasury Secretary Janet Yellen to release more than 150 suspicious activity reports filed by banks regarding foreign transactions and wires to and from Hunter Biden, his businesses and associates. -NY Post

"Right now, we just want the bank records. Those suspicious activity reports were created to help Congress and everyone communicate about foreign suspicious foreign transactions," said Comer. "If you do a major foreign transaction with a country, the bank is probably going to write a suspicious activity report to cover themselves for liability."

'Sighing' Tops Mindfulness for Reduced Stress, Improved Mood

 Cyclic sighing is more effective than mindfulness meditation for improving mood and reducing stress, new research suggests.  

In a randomized controlled study, daily breathwork — especially cyclic breathing, which emphasizes shorter inhalations and prolonged exhalations — was associated with greater improvement in mood and a slower respiratory rate than mindfulness meditation.

"We were pleased that just 5 minutes a day of the breathing exercises positively affected mood and resulted in slower respiratory rate, indicating reduced arousal," co-investigator David Spiegel, MD, who directs the Center for Stress and Health at Stanford University, Stanford, California, told Medscape Medical News.

The findings were published online January 10 in Cell Reports Medicine.

Intentional Breath Control

Controlled breathwork has emerged as a potential tool to manage stress and boost well-being.

In the new study, researchers compared three different daily 5-minute breathwork exercises to an equal amount of mindfulness meditation over 1 month in 108 healthy adults recruited mostly from an undergraduate psychology class at Stanford:

  • 33 participants practiced cyclic hyperventilation, which emphasizes robust inhalation, short retention and rapid exhalation

  • 30 did exhale-focused cyclic sighing

  • 21 performed box breathing, which emphasizes equal duration of inhalation, breath retention, and exhalation

  • 24 practiced mindfulness meditation (the control group)

The primary endpoints were improvement in mood and anxiety, as well as reduced physiologic arousal (respiratory rate, heart rate, and heart rate variability). Physiologic data was collected using a wearable WHOOP strap (WHOOP Inc).

All four groups showed significant daily improvement in mood, as well as reduction in anxiety and negative mood, but there were significant differences between mindfulness meditation and breathwork.

Using a mixed-effects model, the researchers showed that breathwork, especially the exhale-focused cyclic sighing, produced greater improvement in mood (P < .05) and reduction in respiratory rate (< .05) compared with mindfulness meditation.

Specific Patterns vs Passive Attention

The finding supports the team's hypothesis that intentional control over breath with specific breathing patterns produces more benefit to mood than passive attention to one's breath, as in mindfulness meditation practice.

"It turned out that the cyclic sighing was indeed most soothing," Spiegel noted.

"We expected that because of respiratory sinus arrhythmia. Exhaling is accomplished by increasing pressure in the chest, which increases venous return to the heart, triggering parasympathetic slowing of heart rate via the sinoatrial node," he said.

Spiegel added that, conversely, inspiration reduces venous return, triggering sympathetic activity and increased heart rate.

"The magnitude of this heart rate variability is associated with better health, including recovery from myocardial infarction and even cancer survival. So self-soothing is a good thing, and we expected an advantage for cyclic sighing," he said.

"If you're looking to improve sleep and reduce daytime stress, recover from intense work, life and/or training, then interventions that facilitate autonomic control (and indeed you can control it), brief (5 minutes) structured breathwork is among the more powerful (and zero cost) tools," tweeted senior investigator Andrew Huberman, PhD, professor of neurobiology at Stanford.

Immediate Application?

Commenting for Medscape Medical News, Sara Lazar, PhD, Massachusetts General Hospital and Harvard Medical School in Boston, said the findings are "interesting" but cautioned that this is "just one study with a pretty small sample size," and it only enrolled healthy college students.

Lazar, who also runs the Lazar Lab for Meditation Research at Mass General, noted that she would want to see a future study "done with working-age adults and with clinical populations."

"It should also be noted that mindfulness had a bigger effect on negative affect, which could have implications for conditions such as depression or trauma," said Lazar, who was not involved with the current research.

Also weighing in, Steven R. Thorp, PhD, professor at California School of Professional Psychology, Alliant International University, San Diego, told Medscape Medical News the study is "really interesting and well-done."

"Although breathing exercises and breathing retraining are commonly found in psychosocial interventions, especially for anxiety disorders, there have been few empirical studies comparing different breathing protocols," Thorp said.

In this study, the passive observation of breaths (mindfulness) and specific breathwork interventions "all worked to decrease state anxiety; but the breathwork, particularly the cyclic sighing protocol, produced a greater overall reduction in respiratory rate and increase in positive mood," he noted.

"These techniques can be recommended by all clinicians because all clients have access to their breath at all times — and only 5 minutes of daily practice can yield the benefits. Moreover, as the authors note, the immediate benefits may encourage clients to engage with the breathwork and potentially other aspects of treatment," Thorp said.

The study was funded by Victor and Winnie Koo and Tianren Culture and a Stanford School of Medicine Discovery Innovation Award. WHOOP Inc donated the wrist straps used in the study, but was not involved in the study's design or analysis. Huberman is an advisor to WHOOP. Lazar and Thorp have reported no relevant financial relationships.

Cell Rep Med. Published online January 10, 2023. Full text

UnitedHealth blamed for most of Dow decline, while rest of stock market rallies

 The Dow Jones Industrial Average's selloff, in the face of a big rally in the broader stock market, is mostly the fault of one company's stock. UnitedHealth Group Inc. shares tumbled 5.7% in afternoon trading, in the wake of lower-than-expected Medicare Advantage rates proposed in 2024. The health insurer's stock price drop of $28.41, which would be the second-biggest in its history behind only the record $47.00 selloff on March 16, 2020, was shaving about 187 points off the Dow's price. Meanwhile, the Dow was down 201 points, or 06%, with 18 of 30 components losing ground. Meanwhile, the S&P 500 rallied 0.9% and the Nasdaq Composite surged 2.4%. And the number of advancing stocks were outnumbering decliners 1,970 to 1,001 on the NYSE and 2,930 to 1,276 on the Nasdaq.