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Thursday, June 16, 2022

Biden: Americans' 'need for mental health has skyrocketed'

 President Joe Biden told The Associated Press on Thursday that the American people are “really, really down” after a tumultuous two years with the coronavirus pandemic, volatility in the economy and now surging gasoline prices that are hitting family budgets.

He said a recession is not inevitable and bristled at claims by Republican lawmakers that last year’s COVID-19 aid plan was fully to blame for inflation reaching a 40-year high, calling that argument “bizarre.”

As for the overall American mindset, Biden said, “People are really, really down.”

President Joe Biden speaks during an interview with the Associated Press in the Oval Office of the White House, Thursday, June 16, 2022, in Washington. (AP Photo/Evan Vucci)
President Biden said Thursday a recession is not inevitable.
AP
President Joe Biden speaks during an interview with the Associated Press in the Oval Office of the White House, Thursday, June 16, 2022, in Washington. (AP Photo/Evan Vucci)
Biden said GOP claims that last year’s COVID aid plan was fully to blame for inflation reaching a 40-year high was “bizarre.”
AP

“They’re really down,” he said. “The need for mental health in America, it has skyrocketed, because people have seen everything upset. Everything they’ve counted on upset. But most of it’s the consequence of what’s happened, what happened as a consequence of the COVID crisis.”

Speaking to the AP in a 30-minute Oval Office interview, Biden addressed the warnings by economists that the United States could be headed for a recession.

“First of all, it’s not inevitable,” he said. “Secondly, we’re in a stronger position than any nation in the world to overcome this inflation.”

The president said he saw reason for optimism with the 3.6% unemployment rate and America’s relative strength in the world.

“Be confident, because I am confident we’re better positioned than any country in the world to own the second quarter of the 21st century,” Biden said. “That’s not hyperbole, that’s a fact.”

https://nypost.com/2022/06/16/joe-bummer-biden-says-americans-are-really-really-down/

Rhythm Pharmaceuticals Up: Thursday Is PDUFA Goal Date

 Shares of Rhythm Pharmaceuticals Inc., which focuses on drugs for rare genetic diseases of obesity, were recently up 12%, to $3.85.

Thursday is the Prescription Drug User Fee Act goal date for the company's supplemental New Drug Application for Imcivree, for patients with Bardet-Biedl Syndrome or Alström syndrome. The U.S. Food and Drug Administration approved the drug in November 2020 for chronic weight management for patients with three rare genetic conditions.

https://www.marketscreener.com/quote/stock/RHYTHM-PHARMACEUTICALS-I-37977152/news/Rhythm-Pharmaceuticals-Up-12-Thursday-Is-PDUFA-Goal-Date-40744935/

Kintara: FDA Grants Fast Track Designation To Brain Cancer Drug

 The United States Food and Drug Administration (FDA) has granted Fast Track Designation to Kintara Therapeutics’ 

 lead drug candidate VAL-083 for the treatment of patients with newly-diagnosed unmethylated glioblastoma (GBM).

Kintara is currently advancing VAL-083 AGILE clinical study in the phase 2/3 trial to support the development and commercialization of VAL-083 in glioblastoma (GBM).

Robert E. Hoffman, President and CEO, said, “We believe Fast Track Designation is indicative of VAL-083's potential to improve outcomes for patients with GBM, the most aggressive form of brain cancer, Fast Track Designation allows us to work closely with the FDA and may expedite our commercial launch of VAL-083, if approved.”

The company anticipates top-line data readout from the international registrational phase 2/3 GBM AGILE Study around the end of calendar year 2023.

FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.

https://www.benzinga.com/general/biotech/22/06/27718942/kintara-therapeutics-stock-shooting-higher-as-fda-grants-fast-track-designation-to-brain-cancer-d

Migraine Disability Rising in the U.S.

 Migraine prevalence was stable in the U.S. from 2006 to 2016 but the proportion of migraine patients with moderate or severe disability nearly doubled, a systematic review showed.

Across U.S. population-based studies, the proportion of people with migraine with moderate to severe disability rose from 22% in 2004 to 43% in 2016, reported Fred Cohen, MD, of Thomas Jefferson University in Philadelphia.

Disability levels remained high, affecting 42% of people with migraine in 2018, Cohen said during a presentation at the American Headache Society annual meeting.

Migraine disability has been assessed in several large-scale epidemiologic studies over the past 30 years. Looking at serial snapshots may offer insight into changing disease patterns, Cohen observed.

"We set out to do a systematic review to analyze these studies for trends in migraine prevalence and burden over time," he said.

"Migraine and burden has been defined in different ways across various studies," he pointed out. "Some studies have used criteria from the International Classification of Headache Disorders [ICHD], while others have used self-reported diagnosis of migraine or included severe headache."

Cohen and co-authors limited the studies they used in their review to ones published before February 2022 with a representative U.S. sample. The studies all used a migraine screener based on the ICHD. U.S. government surveys that included self-reported medical diagnoses of migraine were excluded.

Disease burden was assessed with the Migraine Disability Assessment Scale (MIDAS), a measure of the effect of headache attacks on daily school, work, home, or social activities over 3 months. MIDAS defines moderate (grade III) or severe (grade IV) disability based on scores of 11 or more points.

A total of 11 population-based studies that assessed either episodic or chronic migraine from 26 publications met the final eligibility criteria.

For the past 30 years, the prevalence in the U.S. population remained relatively consistent: 11.7% to 14.7% overall, affecting 17.1% to 19.2% of adult women and 5.6% to 8.2% of adult men. Migraine prevalence consistently was two to three times higher in women versus men.

Prevalence data for chronic migraine were sparse, with the American Migraine Prevalence and Prevention (AMPP) study reporting a rate of 0.91% (1.29% among females and 0.48% of males), and the Chronic Daily Headache in Adolescents study (C-DAS) reporting a rate of 0.79% among adolescents.

The percentage of patients reporting 15 or more monthly headache days rose from 6.8% in the 2005 AMPP cohort to 11.7% in the 2018 OVERCOME cohort.

The proportion of people with migraine with moderate to severe disability (MIDAS III/IV) also rose from 22% in 2004 to 39% in 2012, and then to 43.2% in 2016. It was 42.4% in 2018. Women consistently reported a higher prevalence of MIDAS III/IV scores than men.

This increase in MIDAS disability was unexpected and needs to be explored, Cohen said. Changes in methodology might account for part of the increase: early studies like the AMPP were mailed questionnaire surveys, while newer studies like OVERCOME used online panels. Notably, response rates have declined over time, which may have led to bias, he added.

It's also possible cultural changes are a factor, Cohen observed. "Nowadays, we have commercials with Serena Williams talking about migraine but in the '90s, we didn't have that," he said. "It wasn't as talked about."

Shifts in national trends like opioid use and unemployment also may contribute to migraine disability, as may environmental stresses and triggers, Cohen noted. The next steps involve analyzing the most recent OVERCOME data from 2020 and examining the role migraine treatment patterns might play, he added.


Disclosures

Rubio questions Harvard on Fauci-China cover-up

 Senator Marco Rubio today sent a strongly worded letter to Harvard president Lawrence Bacow expressing concerns prompted by a Spectator magazine investigation by this reporter that Harvard may be “actively supporting [America’s] principal adversary,” the Chinese Communist Party.

“Throughout the pandemic, we were told to trust the experts,” Rubio told The Spectator exclusively. “But what we increasingly see is so-called trusted experts and institutions engaged in highly questionable behavior. This looks really bad, and if it turns out to be true, any last shred of faith that the American people had in these ‘experts’ will be deservedly stamped out. We need to get to the bottom of Covid-19’s origins, but we also need to identify those who misled us and determine whether it was at the direction of the Chinese Communist Party.”

The article — read here — uncovered questionable relations between Harvard Medical School and CCP-tied real estate giant Evergrande over attempts to reach Anthony Fauci at the most sensitive moment in the scientific debate on the origin of the pandemic.

“It has come to my attention that in the early days of the Covid-19 outbreak in the United States, you, Harvard Provost Alan Garber, and Harvard Medical School Dean George Daley facilitated what would become a concerning relationship between Dr. Anthony Fauci and the Chinese property developer Evergrande,” Rubio writes in the previously unreported letter, which puts to Bacow the question of whether Harvard informed the FBI of these activities.

The article uncovered what one source, a senior figure in the US science establishment, characterized as a Chinese attempt to use the nine-figure donation to marshal Harvard faculty and experts who “could be relied on to support, or at least not oppose, the false narrative concerning the origin of the pandemic.”

Rubio’s letter detailed a several pointed questions, including:

“Did you, or other members of Harvard’s administration, contact the Federal Bureau of Investigation or other law enforcement agencies with concerns about Evergrande’s attempt to contact Dr. Fauci through Harvard?”

“When Evergrande Founder and CCP member Xu Jiayin contacted you in January 2020, he reportedly asserted that there had been no interaction between the National Institute for Health or the US Centers for Disease Control and Prevention and their counterparts in the PRC. Were you not aware that Dr. George Gao, the director-general of the Chinese CDC, had not only been in contact with Dr. Robert Redfield, the US CDC director, on multiple occasions since the beginning of January but that Gao had also refused support offered by the United States?”

“When Harvard Medical School Dean George Daley contacted Dr. Fauci on February 2, 2020, had Evergrande already communicated its intent to pledge $115 million to Harvard Medical School?”

Rubio has been one of the most outspoken voices in the Senate on the question of the pandemic’s origin and China’s role in mishandling the outbreak by withholding information in the crucial early days of the pandemic. Rubio also engaged in a tense round of questioning with Fauci during a Senate Appropriations Committee hearing on the topic of NIH funding of labs like the one in Wuhan.

Rubio also noted that: “According to reporting by The Spectator, these interactions apparently shaped two subsequent developments: 1) a donation by Evergrande to Harvard Medical School to the tune of $115 million, and 2) a decision by US scientists and public health officials, including Dr. Fauci, to publicly dismiss the possibility that the novel coronavirus emerged as a result of a research-related incident, likely at the state-run Wuhan Institute of Virology, after these same scientists and officials had discussed this very hypothesis in private and deemed it plausible.”

Rubio’s Harvard letter calls attention to the “coincidental timing of these events” that “suggests the possibility of a quid pro quo, whereby Harvard officials, in return for a large donation from Evergrande, contacted American public health officials to convince them that Chinese Communist Party’s preferred theory of the origin of Covid-19 was the only theory that should be seriously considered.”

Rubio, who serves as vice chairman of the Senate Select Committee on Intelligence and is a member of the Senate Committee on Appropriations, cited his “responsibility to the American taxpayer to ensure that recipients of federal funding, like Harvard, are not complicit in the CCP’s malicious attempts to subvert the interests of the United States, including the search for the origin of Covid-19.”

The letter requests details of a meeting between George Daley and Evergrande officials referenced by Daley in his email to Fauci and asks for the full and un-redacted contacts of that email, which contains significant unexplained redactions.

Rubio concludes by noting that, “The United States has entered an era of great power competition with the CCP, a regime that has explicitly called for the displacement of the United States as the world’s leading power. It is incumbent on all Americans to be vigilant against the CCP’s attempts to weaken the United States and our institutions, including our educational institutions.”

The question of the origin of the pandemic, once cast as conclusively coming from an unidentified animal, is now back in the limelight. While there has been significant debate concerning the science surrounding the origin of SARS-CoV-2, there has been comparatively little investigation into the role powerful institutions like Harvard might have played in shaping, or, in some cases, contorting, this debate.

This is a key line of inquiry into what might constitute malfeasance surrounding the most consequential story of this generation, with more major breaking news in coming weeks.

https://spectatorworld.com/topic/exclusive-rubio-questions-harvard-on-fauci-china-lab-leak-cover-up/

Intellia started at Buy by B of A

 Target $70

https://finviz.com/quote.ashx?t=NTLA&ty=c&ta=1&p=d

Walgreens: Clinical Trial Business to Address Industrywide Access and Diversity Challenges

 Walgreens today announced the launch of its clinical trial business to redefine the patient experience and increase access and retention in sponsor-led drug development research. Walgreens flexible clinical trial model combines the company’s vast foundation of patient insights, partner-enabled health and technology capabilities and in-person and virtual care options to break through barriers to engaging broader and more diverse communities.

The introduction of Walgreens clinical trial offerings coincides with recent steps taken by the U.S. Food and Drug Administration to increase racial and ethnic diversity in clinical trials given 20 percent of drugs have a variation in responses across ethnic groups1, yet 75 percent of clinical trial participants are white, while only 11 percent are Hispanic and fewer than 10 percent are Black and Asian2.

“Walgreens trusted community presence across the nation, combined with our enterprise-wide data and health capabilities, enables us to pioneer a comprehensive solution that makes health options, including clinical trials, more accessible, convenient and equitable,” said Ramita Tandon, chief clinical trials officer, Walgreens. “Through the launch of our clinical trials services, we can provide another offering for patients with complex or chronic conditions in their care journey, while helping sponsors advance treatment options for the diverse communities we serve. This is yet another way we are building our next growth engine of consumer-centric healthcare solutions.”

Patient recruitment and enrollment remain challenges in clinical trials, further exacerbated by the COVID-19 pandemic. Nearly 80 percent of trials fail to meet their enrollment goals in the stated timeframes, often contributing to costly delays3. Walgreens is addressing these challenges and improving the overall clinical trial experience by rapidly scaling three portfolio-integrated, patient-centric service lines:

https://www.businesswire.com/news/home/20220616005208/en/Walgreens-Launches-Clinical-Trial-Business-to-Address-Industrywide-Access-and-Diversity-Challenges-and-Redefine-Patient-Experience