Dallas Fed President Rob Kaplan on Thursday said he will press his colleagues to agree to announce a plan to start "tapering" or slowing down asset purchases in September, and to then launch the program in October or November. Kaplan had made headlines last week when he said the spread of the coronavirus delta variant might cause him to rethink this aggressive timetable. In an interview with CNBC, Kaplan said he has reviewed the latest data and wants to go ahead with his initial plan for the September taper announcement because Americans are adjusting to the delta variant. "What we're seeing is consumers and businesses are just becoming more adaptable," Kaplan said. "We're seeing resiliency." Stocks were lower on Thursday with the Dow Jones Industrial Average [s:DJIA] down almost 100 points in late morning trading.
Thursday, August 26, 2021
New Biomarker for Early Alzheimer's and Parkinson's?
Olfactory bulb volume (OBV) was associated with odor identification and mediated the link between volumes of central olfactory brain structures and olfactory function in older adults, a cross-sectional study showed.
Larger OBV was associated with better olfactory function scores on the SIT-12, a 12-item Sniffin' Sticks smell test, with a difference in score of 0.46 points (95% CI 0.29-0.64), independent of sex, nasal patency, and smoking status, reported Monique Breteler, MD, PhD, of the German Center for Neurodegenerative Diseases in Bonn, and co-authors.
Larger OBV also correlated with larger volumes of several brain regions involved in processing olfactory information, including the amygdala, hippocampus, insular cortex, and medial orbitofrontal cortex. OBV mediated the association between the amygdala, parahippocampal cortex, and hippocampus volumes and olfactory function in older participants.
"This cross-sectional study found that olfactory bulb volume was independently associated with odor identification function and was a robust mediator of the age-dependent association between volumes of central olfactory structures and olfactory function," Breteler and colleagues wrote in JAMA Otolaryngology–Head & Neck Surgery.
"Thus, neurodegeneration-associated olfactory dysfunction may primarily originate from the pathology of peripheral olfactory structures, suggesting that OBV may serve as a preclinical marker for the identification of individuals who are at an increased risk of neurodegenerative diseases," they added.
Olfactory structures are affected early in Alzheimer's disease and Parkinson's disease, before cognitive symptoms emerge. Impaired olfactory function is among the earliest signs of neurodegenerative disorders and has been associated with cognitive decline in dementia-free older adults.
Olfactory dysfunction also has emerged as one of the earliest and most frequent neurological signs of SARS-CoV-2 infection. "However, little is known about the neuroanatomical basis of olfactory dysfunction in the general population, elucidation of which could not only provide insights into its underlying causes but also facilitate the identification of individuals who are at an increased risk of neurodegenerative conditions," Breteler and co-authors noted.
The researchers used data from the Rhineland Study, an ongoing population-based cohort study that aims to identify risks and biomarkers for neurodegenerative diseases. Participants were enrolled from March 2016 to October 2017 and underwent 3T brain MRI and olfactory assessment. Smoking and nasal patency information was self-reported and performance on the SIT-12 was used as a proxy for olfactory function.
Analyses included 541 participants with a mean age of 53.6; nearly 57% were women. Increasing age, male sex, and nasal congestion were associated with worse olfactory function on the SIT-12.
Larger volumes of amygdala (difference in OBV 0.12, 95% CI 0.01-0.24), hippocampus (0.16, 95% CI 0.04-0.28), insular cortex (0.12, 95% CI 0.01-0.24), and medial orbitofrontal cortex (0.10, 95% CI 0.00-0.20) were associated with larger OBV. Larger volumes of amygdala (volume × age interaction effect 0.17, 95% CI 0.03-0.30), parahippocampal cortex (0.17, 95% CI 0.03-0.31), and hippocampus (0.21, 95% CI 0.08-0.35) were associated with better olfactory function, but only in older age groups.
There's a need for better biomarkers to identify people at risk of neurodegenerative disorders, observed Subinoy Das, MD, of the U.S. Institute for Advanced Sinus Care and Research in Columbus, Ohio, in an accompanying editorial. "A decrease in OBV could warn clinicians about the increased risk for neurodegenerative disease and serve as a marker for therapeutic responses to improve smell," he wrote.
"Much more work is needed," Das pointed out. "Ideally, the OBV could be replaced with a maximal olfactory bulb width to simplify the measurements for widespread clinical use, and reference ranges based on age and sex will need to be created."
The study has several limitations, Breteler and colleagues acknowledged. Analyses were based on cross-sectional, not longitudinal, data. Odor identification was used as a proxy for olfactory function, but it is a subtask of the complete olfactory testing battery. Subjective nasal patency assessment may have led to less precise estimates of associations between imaging measures and olfactory function, they added.
Disclosures
One researcher was funded by the China Scholarship Council. No other conflicts of interest were reported.
Das is affiliated with the U.S. Institute for Advanced Sinus Care and Research, which manufactures SmellRegen, an olfactory retraining kit. He also is the chief medical officer of Tivic Health Inc.
Primary Source
JAMA Otolaryngology–Head & Neck Surgery
Secondary Source
JAMA Otolaryngology–Head & Neck Surgery
https://www.medpagetoday.com/neurology/generalneurology/94217
'Pandemic of the Unvaccinated?' Not Really, Advocate Says
Is the current COVID-19 surge a "pandemic of the unvaccinated?" No, according to Rhea Boyd, MD, MPH, pediatrician and co-developer of the "The Conversation: Between Us, About Us" project to encourage more people of color to get vaccinated.
"This is not a pandemic of the unvaccinated," Boyd said Wednesday at a virtual event sponsored by the Alliance for Health Policy. Instead, "what we really exposed during the vaccination distribution effort is just how unequal the United States is" when it comes to getting access to COVID-19 vaccines. She presented data from the New York Times and the Kaiser Family Foundation showing that vaccine distribution was worse in Southern states, which also are where more Black and Latinx people live (the conversation is a joint project of the Kaiser Family Foundation and the Black Coalition Against COVID).
In addition to the vaccine distribution problem, "we also know this is an area of the country where access to insurance is not evenly distributed because these are states who have disproportionately been less likely to expand Medicaid," she said. "So what that means is now 97% of adults in this country who live in the coverage gap, which means their income is too high to qualify for Medicaid, but too low to be eligible for the [Affordable Care Act] marketplace or premium tax credits -- those folks who then just simply lack coverage -- mostly live in the South," particularly in states like Texas and Florida "which are states where we're all seeing surges and we're seeing lower rates of vaccination."
Boyd noted that CDC data released Monday showed that a smaller percentage of Black and Latinx individuals in the U.S. have been fully vaccinated compared with whites. One barrier for many of these unvaccinated people is cost: although they know that the vaccine itself is free, "getting to that vaccination site requires gas in your tank, it requires bus fare. It might require a parking fee if you go to a public site in the community," she said. "Getting to and from healthcare always costs money, and that is a concern for people who are low-income, and we've seen that people who are low-income are more likely to be disproportionately unvaccinated."
Taking time off of work is another barrier, especially when it comes to getting children vaccinated, she continued; one poll found that 25% of all parents who had unvaccinated children, ages 12 to 17, said they would be more likely to get their children vaccinated if they were given paid time off to do so, she said. They would also be more likely to get vaccinated themselves "if their medical provider could come to their workplace to do it," Boyd added.
The information gap is another problem for lower-income people. "We are also facing an information gap in communities that mirrors the health literacy gap that has existed in this country for decades, if not centuries," she said. "People who have access to resources and healthcare tend to have access to credible information about health, and other communities do not. On top of that information gap, we are obviously also facing a disinformation campaign that's been targeting communities of color, particularly Black folks, since the beginning of the vaccine rollout."
"Our nation's unvaccinated are not a monstrous monolith," Boyd said. "This is not a group who is adverse to science, or medical care. We have seen that this is a group who is more likely to be our nation's working poor; they're more likely to lack the resources to actually access any type of healthcare, let alone a vaccination. And so if we're going to vaccinate them, we have to talk about what we're going to do to address access barriers both to the vaccines and other types of medical care, but also to information about vaccines."
For instance, "we need to talk about universal healthcare, so that the cost of vaccination truly is free for folks," she continued. "We need to talk about paid sick leave ...We need to acknowledge that disinformation is rarely behind a paywall, but credible science often is, and so we need to make sure that -- particularly around COVID and health in general -- that we provide free access to everybody to have that information online and in their community."
Boyd also urged people to stop using the term "vaccine hesitancy." "People don't have a kind of amorphous hesitation or reluctance to get vaccinated or to receive medical care," she said. "Most of those who are unvaccinated in our country are not 'anti-vaxxers' -- that is a tiny minority of the folks who are unvaccinated." Many of the unvaccinated are actually children, which "obviously blows open the idea that the folks who are unvaccinated just hate medical care and vaccines. So if we're not going to talk about hesitancy, it means you have to do the extra work to actually understand why folks aren't vaccinated."
Also during the event, Henry Fernandez, CEO of the African American Research Collaborative, which recently polled more than 12,000 people regarding their attitudes on vaccination, was asked whether he thought that the FDA's granting of full approval to the Pfizer/BioNTech COVID-19 vaccine was likely to result in more people being vaccinated. Fernandez said he didn't see that approval per se would convince people, but that the employer and government mandates that are likely to follow full approval would have an impact.
"About a third of the unvaccinated said just even a request from their employer would lead them to get vaccinated," he said. "We also saw that larger financial incentives actually had quite a significant impact ... and there's probably no more significant financial incentive than the loss of a job."
https://www.medpagetoday.com/infectiousdisease/covid19vaccine/94211
KC Fed president: Tapering should begin 'sooner rather than later'
Kansas City Federal Reserve President Esther George said Thursday tapering should begin "sooner rather than later," ahead of the Jackson Hole meeting.
"Certainly the inflation numbers are coming in strong, and would suggest that there's an opportunity to begin to dial back on asset purchases," George told FOX Business’ Edward Lawrence during an exclusive interview.
In its latest policy meeting, the Federal Reserve revealed that it could start tapering asset purchases as early as the end of this year.
"Looking ahead, most participants noted that, provided that the economy were to evolve broadly as they anticipated, they judged that it could be appropriate to start reducing the pace of asset purchases this year because they saw the Committee's "substantial further progress" criterion as satisfied with respect to the price-stability goal and as close to being satisfied with respect to the maximum-employment goal," the summary of the July Federal Open Market Committee meeting minutes stated.
George said the "communication about that coming out of the September meeting will reflect the deliberations and the views of the Committee on how that progress is being achieved."
The Fed cut interest rates to zero at the height of the coronavirus pandemic and began purchasing $80 billion a month in Treasury securities and $40 billion in mortgage securities in an effort to provide additional stimulus to the economy. In December, Fed officials said they would want to see "substantial further progress" toward meeting their goals of inflation around 2% and labor market conditions consistent with full employment.
While various officials said a reduction could come in the "coming months," others indicated that it would more likely become appropriate early next year, noting that the transitory nature of the year's rise in inflation, as well as the recent declines in "longer-term yields and in market-based measures of inflation compensation," cast doubt on the degree of progress that has actually been made toward the price-stability goal since December.
Some participants warned that the committee should be prepared to start tapering "relatively soon, in light of the risk that the recent high inflation readings could prove to be more persistent than they had anticipated." In addition, committee members emphasized the importance of clearly reaffirming "the absence of any mechanical link between the timing of tapering and that of an eventual increase in the target range for the federal funds rate."
Although George is unsure of the timeline for getting asset purchases tapered off, she pointed out that as she watches the "economy unfolding," it's better to do it "sooner rather than later."
The baseline outlook that we are going to continue to see job gains, continue to see strong growth, it suggests that we can begin to make some of those adjustments this year," she said, adding that, "I think that's going to be an important first step to judging how the economy unfolds."
George went on to say that she is in favor of "continuing to back out of this the way we went into it."
"There was not an intent going in to buy mortgage-backed securities related to the housing market. I understand now the housing market is looking particularly frothy but backing away from those asset purchases is really designed to achieve a broader objective, and that is to remove, in a systematic way, accommodation as the economy gets stronger," George explained.
George also believes the U.S. economy will achieve "high growth" at a rate of 6 to 7% this year.
https://www.foxbusiness.com/economy/kc-fed-president-us-economy-ready-for-tapering-measures
AstraZeneca: ALXN1840 Met Primary Endpoint in Phase 3 Trial for Wilson Disease
AstraZeneca PLC said Thursday that ALXN1840 met the primary endpoint in a FoCus Phase 3 trial for Wilson disease, showing an improvement in copper mobilization from tissues.
The pharmaceutical giant said that ALXN1840 demonstrated about three times more copper mobilization from tissues than standard-of-care treatments.
Wilson disease is a rare and progressive genetic condition in which the body's pathway for removing excess copper is compromised.
Separately AstraZeneca said that Forxiga has been approved in Japan for the treatment of chronic kidney disease in patients with and without type-2 diabetes.
Virpax in Manufacturing/Supply Agreement for Pain Med
Virpax® Pharmaceuticals, Inc. ("Virpax" or the "Company") (NASDAQ:VRPX), a company specializing in developing product candidates for pain management, CNS and anti-viral indications, today announced that it has entered into a commercial manufacturing and supply agreement with Seqens, an integrated global leader in pharmaceutical solutions with 24 manufacturing sites worldwide and seven research and development facilities throughout the U.S. and Europe.
The agreement with Seqens provides for both the supply material for Virpax’s clinical studies as well as the long-term commercial supply of MMS019. Seqens will conduct process development and validation of additional large scale commercial quantities of MMS019 at its facilities in Devens and Newburyport, Massachusetts.
"Establishing a collaboration with a strong partner capable of supplying clinical and commercial scale quantities of MMS019 is another important advancement in our MMS019 product development strategy. Seqens has a demonstrated expertise in developing and manufacturing highly-complex molecules for large scale production," said Anthony Mack, Chairman and CEO of Virpax. "Importantly, we expect this collaboration to support future development and supply additional Molecular Envelope Technology programs under development, including Envelta™ and PES200, our post-traumatic stress disorder product candidate," concluded Mr. Mack.
About MMS019
MMS019 is a drug product candidate based on a type of nanotechnology that enables the exclusive delivery of a metabolically labile peptide drug into the brain via intranasal delivery. MMS019 is manufactured using industrially relevant equipment and processes (high pressure homogenization and spray drying). There is pharmacological evidence of activity of molecular envelope technology (MET) enabled enkephalin in morphine-tolerant animals. The MET nanoparticles are well tolerated via the nasal route at the dose administered. MMS019 demonstrated comparable preclinical activity to morphine in all animal pain models tested without the drug seeking and tolerance associated with opioids.
https://finance.yahoo.com/news/virpax-announces-mms019-manufacturing-supply-130000918.html