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Tuesday, January 31, 2023

Heart, Vein Disease Deaths High In 25-To-44-Year-Olds

 by Petr Svab via The Epoch Times (emphasis ours),

Diseases of the heart and veins claimed more lives over the past several years among American aged 25 to 44 than before the COVID-19 pandemic. Even with the pandemic waning, such deaths remain elevated.

In 2020, the first year of the pandemic, deaths caused by circulatory diseases increased by about 15 percent in the 25 to 44 age group compared to the year before, according to death certificate data collected by the Centers for Disease Control and Prevention (CDC).

In 2021, such deaths increased by more than 20 percent compared to 2019.

That means nearly 6,500 more deaths.

(ZH: Related)

It appears that the increase may have been caused by multiple factors.

COVID-19 sometimes causes complications in the circulatory system. It’s likely that some deaths, especially early on in the pandemic, were caused by COVID-19 but were misclassified on the death certificate.

Also, many people were likely diagnosed too late or not at all because they were afraid to go to a doctor during the pandemic.

However, diseases of the circulatory system continued to claim lives at a higher rate in this age group even in 2022, when the pandemic receded. In the first half of the year, such deaths were still more than 13 percent above the death toll for the first half of 2019, according to the CDC’s preliminary data.

In the 45 to 54 age group, such deaths increased in 2020–21 but seem to have since receded back to pre-pandemic levels.

In the 15 to 24 age group, such deaths have barely budged over the past five years.

A growing number of experts and studies have associated the COVID-19 vaccines with serious, even fatal conditions, including heart inflammation, or myocarditis. They suggest that the spike protein produced through the vaccination can cause blood clotting and inflammation.

“All cardiovascular conditions have gotten worse because of the vaccine and anything and everything that can go wrong with the heart has gone wrong with the heart as a result of these mRNA vaccines. There’s no doubt about it,” said Dr. Aseem Malhotra, a British cardiologist who has researched extensively the associations between the COVID-19 vaccines and heart issues.

Malhotra has argued that such issues should be presumed to be associated with the vaccines until proven otherwise. He initially supported the vaccines but changed his mind after his father’s cardiac arrest six months after vaccination.

Dr. Peter McCullough, a highly published American cardiologist, independently reached a similar conclusion.

When people are in a study or it’s in a post-marketing period in a brand-new drug, when someone dies within a few days, or certainly within 30 days of any new drug or injection, it is that drug until proven otherwise,” he told Epoch TV’s Jan Jekielek last month.

“If this was in a regulatory dossier, it could even be something that’s seemingly disconnected. Believe it or not, in clinical trials, if someone’s taking a drug and they have a car accident, it’s attributed to the drug, because the drug may have made them dizzy or foggy or what have you.”

The rollout of the vaccines also correlates with significant increases in other conditions, including eye problems, immune system issues, and, in some data, cancer, according to Josh Stirling, an insurance research analyst.

Overall, the vaccination correlates with increased mortality, according to Stirling.

“The more doses on average you have in a region within the United States, the bigger increase in mortality that region has had in 2022 when compared to 2021,” he recently told Jekielek in an interview for “American Thought Leaders.”

Stirling has argued that if the vaccine’s adverse effects are properly identified, they could be mitigated.

“If we were actually just screening for these people, the vast majority of these health issues, before they become catastrophic, could very easily be managed—not necessarily solved, but certainly managed with amazing medical advances and simple things like blood thinners, or changes in lifestyle,” he said.

Mortality in prime-age adults aged 18 to 64 substantially increased in 2020 and onward, even with COVID-19 deaths excluded, according to a Dec. 15, 2022, paper that attempted to account for COVID-19 deaths misclassified on death certificates.

https://www.zerohedge.com/political/heart-vein-disease-deaths-high-25-44-year-olds

What Happens When Patients Stop Weight-Loss Medications?

 Ania Jastreboff, MD, PhD, a professor at Yale School of Medicine and director of weight management and obesity prevention at Yale Stress Center in New Haven, Connecticut, discusses what to expect when stopping obesity medications like semaglutide (Wegovy).

The following is a transcript of her remarks:

Semaglutide, like other medications that are used for obesity treatment, have to be taken long term. Just as for any other chronic disease, if a medication is stopped for any reason, the disease is no longer being treated. So, for example, if somebody is taking a medication for hypertension, if you stop that anti-hypertensive medication, the blood pressure goes up and we're not surprised.

In the same way, if someone is taking a medication for obesity treatment, when it is stopped, weight gain occurs -- or weight regain occurs, more accurately.

Why is this? Obesity is a chronic disease. It's a neurometabolic disease, meaning that our body and our brain talk to each other. What happens is our body is very, very smart. It wants to carry a certain amount of fuel, and the way that our body does this is by carrying fat. Our body does not want to carry too little fat because then we would starve, and our body also doesn't want to carry too much fat because then we would not be able to do the things that we need to do and have our body function well.

So there's a sweet spot, and we call that sweet spot the "defended fat mass set point." It's basically the amount of fuel or the amount of fat that your body wants to carry.

Now, within the context of our current obesogenic environment -- an environment with all of these highly palatable and highly processed foods, the lack of sleep, the lack of movement and physical activity, stress -- all these different things in our obesogenic environment has pushed up the defended fat mass set point on a population level.

What do these medications like semaglutide do? They decrease that defended fat mass set point, and a consequence of that is that we lose weight.

So what happens when someone takes an anti-obesity medication and then stops taking that medication? Let's say they've lost 40 or 50 pounds and the medication is stopped. Well, what happens is that the defended fat mass set point goes back up and the weight follows.

During the course of our body wanting to regain that weight because the treatment was stopped, patients can be very hungry, they can have cravings, and basically their body is wanting to go back up to that higher defended fat mass set point again because the treatment was discontinued.

The key and the take-home message here is that in order to maintain that lower or re-regulated defended fat mass set point, the medication has to be continued. In order to maintain that weight reduction, the medication has to be continued, and that is because obesity is a chronic disease. For any chronic disease, we have to treat it lifelong.

https://www.medpagetoday.com/endocrinology/obesity/102894

'High Rates of Psychiatric Disorders' in Patients With Alopecia Areata

 Patients with alopecia areata (AA) had rates of anxiety and depression two to three times higher than the general population, and more than a third had suggestive symptoms, according to a meta-analysis of published data.

The results showed a 9% prevalence of depression and 13% prevalence of unspecified anxiety disorders. Additionally, 37% of the patients had depressive symptoms and 34% had anxiety symptoms. Variations in prevalence estimates could be explained by methodologic differences among the 55 studies included in the analysis.

Given the disparity between the prevalence of the disorders and symptoms, a multimodal approach to assessment in research might lead to improved detection of psychiatric disorders in patients with dermatologic conditions, concluded Isabelle Jalenques, MD, PhD, of CHU Clermont-Ferrand in France, and co-authors, in JAMA Dermatology

opens in a new tab or window.

"This meta-analysis is, to our knowledge, the first to make separate assessments of depressive and anxiety disorders and symptoms in patients with AA," the researchers stated. "By distinguishing between disorders and symptoms, this analysis yielded more accurate data and also provided the prevalence of each anxiety disorder. This factor is important because prevalence varies according to the different disorders.

"However, given the small number of studies identified, caution should be exercised about their actual prevalence," the team continued. "Only phobia did not seem to be associated with AA."

The results are consistent with literature on the associations between dermatologic conditions and psychiatric disorders, but expand on the evidence by distinguishing between psychiatric disorders and symptoms. Two recent meta-analyses assessed associations in patients with AA. One analysis showed a positive association with anxiety and depression, and the other found a greater prevalence of anxiety and depression.

However, the two studies focused on the prevalence of anxiety and depression without distinguishing the disorders from symptoms, Jalenques and co-authors noted. Depending on the assessment methodology, inaccurate estimates can occur, particularly with respect to overestimate of psychiatric prevalence.

"The exact magnitude of the association between AA and depressive disorders or symptoms and anxiety disorders and symptoms is unknown," the authors said.

In an effort to bring more clarity to the estimates and associations, the investigators performed a systematic review and meta-analysis of relevant published studies. The team conducted separate analyses of the prevalence of the psychiatric disorders and prevalence of symptoms.

Beginning with 1,099 records, the authors honed the list to 55 studies that evaluated depression and anxiety in children and adults with AA -- 29 studies related to depression and 26 to anxiety. The studies represented 20,176 patients evaluated for depressive disorders, 1,966 for depressive symptoms, 40,877 patients for anxiety disorders (primarily phobias, unspecified disorders, and obsessive-compulsive disorder), and 1,621 for anxiety symptoms.

Using published literature, the authors identified prevalence estimates of 3.8% and 7.3% for depressive disorders

opens in a new tab or window and unspecified anxiety disordersopens in a new tab or window, respectively, in the general population. The 9% prevalence estimate for depressive disorders from the meta-analysis translated into an odds ratio of 1.38 versus the general population. The 13% estimate for anxiety disorders included a range of 7-17% for different types of disorders, resulting in odds ratios of 1.51-1.69.

The 37% prevalence of depressive symptoms in patients with AA represented an odds ratio of 2.70 versus the general population, and the 34% prevalence of anxiety symptoms represented a threefold increase (OR 3.07).

"It would be interesting to follow the evolution of the severity and number of these symptoms, which are warning signs that need monitoring because they can develop into disorders," the authors said in conclusion. "The substantial difference between the prevalence of disorders and that of symptoms is a strong argument in favor of using a multimodal assessment approach in research studies that could lead to a better detection of psychiatric disorders in patients with dermatological diseases."

Disclosures

The authors reported having no relevant relationships with industry.

Primary Source

JAMA Dermatology

Source Reference: opens in a new tab or windowLauron S, et al "Prevalence and odds of depressive and anxiety disorders and symptoms in children and adults with alopecia areata. A systematic review and meta-analysis" JAMA Dermatol 2023; DOI: 10.1001/jamadermatol.2022.6085.


https://www.medpagetoday.com/dermatology/generaldermatology/102901

Prothena Alzheimer's Med Hits Safety Goal in Phase 1

 

  • Results from a single ascending dose (SAD) study in healthy volunteers demonstrated dose-proportional PRX005 concentrations in plasma with robust central nervous system (CNS) penetration of this potentially best-in-class investigational anti-MTBR-tau antibody
  • Single doses of PRX005 across three dose cohorts were generally safe and well tolerated, meeting the primary objective of the study
  • The Phase 1 multiple ascending dose (MAD) portion of the study is ongoing in healthy volunteers and patients with Alzheimer’s disease; topline results are expected by year end 2023

Biosynex and Chembio Diagnostics Announce Definitive Acquisition Agreement

 Complementary Technologies, Product Portfolios, and Market Opportunities Expected to Represent Significant Growth Drivers

Consolidated Manufacturing, Sales, Marketing, Operations to Provide Synergistic Cost Savings

Biosynex SA (“Biosynex”) (EPA: ALBIO), a French market leader specializing in the design and distribution of rapid tests, and Chembio Diagnostics, Inc. (“Chembio”) (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced that the companies have entered into a definitive merger agreement under which Biosynex, through a subsidiary, will acquire Chembio for $0.45 per share, representing a premium of 27% compared to the closing price of Chembio stock on January 30, 2023, in an all-cash transaction valued at $17.2 million.

The acquisition combines two leading rapid diagnostic test companies. Each company specializes in the development, manufacturing and marketing of point-of-care diagnostic tests for the professional and at home markets. Chembio, based in the United States, focuses on infectious disease assays covering sexually transmitted infections, respiratory viruses and fever and tropical disease, built on the DPP, SURE CHECK and STAT-PAK proprietary, accurate and easy-to-use technology platforms. Biosynex, based in France, provides pharmacies and professional healthcare settings with a diversified portfolio of rapid tests covering different market segments including infectious disease and women’s health tests, Point of Care devices and molecular diagnostics systems. Biosynex will operate Chembio and its 100% owned German, Brazil and Malaysia subsidiaries as a wholly owned group.

https://finance.yahoo.com/news/biosynex-chembio-diagnostics-announce-definitive-220000979.html

Chronic disease biotech Structure Therapeutics sets terms for $125 million IPO

 Structure Therapeutics, a Phase 1 biotech developing G-protein-coupled receptors for chronic diseases, announced terms for its IPO on Monday.


The South San Francisco, CA-based company plans to raise $125 million by offering 9.0 million ADSs at a price range of $13 to $15. At the midpoint of the proposed range, Structure Therapeutics would command a fully diluted market value of $511 million.

Headquartered in California with R&D operations in China, Structure Therapeutics aims to develop and deliver novel oral therapeutics for a wide range of chronic diseases with unmet medical needs. Its initial focus is on G-protein-coupled receptors (GPCRs), which regulate numerous physiological and pathological processes. The company's lead candidate, GSBR-1290, is an oral small molecule agonist of GLP-1R, a validated GPCR drug target for type-2 diabetes mellitus and obesity. Structure Therapeutics completed a Phase 1 single ascending dose study of GSBR-1290 in September 2022, and initiated a Phase 1b multiple ascending dose study in January 2023. The company expects to initiate a Phase 2a proof-of-concept study in the 2H23.

Structure Therapeutics was founded in 2016 and plans to list on the Nasdaq under the symbol GPCR. Jefferies, SVB Leerink, Guggenheim Securities, and BMO Capital Markets are the joint bookrunners on the deal. It is expected to price during the week of January 30, 2023.

Amgen revenue falls slightly as Lilly COVID deal contributes less

 

Amgen Inc on Tuesday said its fourth-quarter revenue fell slightly as a 4% increase in sales of its own drugs was offset by lower revenue from its deal to manufacture COVID-19 antibody treatments for Eli Lilly and Co.

Amgen reported revenue of $6.84 billion in the quarter, down from $6.85 billion a year ago, but ahead of analysts' estimates of $6.77 billion, according to Refinitiv data.

Amgen partnered with Lilly in 2020 to increase the supply of its COVID-19 antibody treatments. U.S. health regulators pulled the authorization for Lilly's last COVID antibody in November after determining it would not be effective against currently circulating coronavirus variants.

The biotechnology company's listed "other revenue," which includes the manufacturing deal, fell to $287 million from $575 million last year.

Amgen product sales were led by a 14% jump in osteoporosis drug Prolia to a quarterly record of $992 million.

Adjusted earnings per share decreased to $4.09 from $4.40 a year ago, just missing analyst estimates of $4.10. Net income fell 15% to $1.62 billion.

The biotechnology company forecast 2023 revenue of $26 billion to $27.2 billion, excluding the impact of its anticipated acquisition of Horizon Therapeutics Plc. The company expects to provide an updated forecast once that deal closes.

Analysts estimate $27.17 billion in revenue for the full year, according to Refinitiv.

Earlier in December, Amgen agreed to buy Horizon in a deal valued at $27.8 billion, fortifying its rare diseases portfolio with the access to the blockbuster thyroid eye disease treatment Tepezza.

"The announced acquisition of Horizon Therapeutics, which we expect to complete in the first half of this year, represents a compelling opportunity to serve more patients and strengthen our growth profile," Amgen Chief Executive Robert Bradway said in a statement.

Earlier on Tuesday, Amgen launched Amjevita, the first U.S. biosimilar of AbbVie Inc's blockbuster arthritis treatment Humira. It began selling it in Europe in October 2018 after Humira first went off patent.

https://www.marketscreener.com/quote/stock/AMGEN-INC-4847/news/Amgen-revenue-falls-slightly-as-Lilly-COVID-deal-contributes-less-42860286/