'Popular' Paper On Ivermectin Ineffectiveness v. COVID-19 Contains False Info

 by Zachary Stieber via The Epoch Times (emphasis ours),

A popular study that claims ivermectin has shown no effectiveness against all-cause mortality contains false information but remains uncorrected.

The meta-analysis, published in 2021 by the journal Clinical Infectious Diseases, explores how groups in randomized, controlled trials fared after receiving ivermectin compared to control groups.

Among five trials included for the portion on all-cause mortality, none showed an effect for ivermectin, the authors claimed.

Ivermectin “did not reduce all-cause mortality,” they wrote.

But the claim is wrong. One of the five trials was described as finding ivermectin recipients were more likely to die, but actually found that ivermectin recipients were less likely to die. “The risk base estimation ... confirmed that the average mortality obtained in all of ivermectin treated arms was 3.3%, while it was about 18.3% in standard care and placebo arms,” the authors of that paper said.

Dr. Adrian Hernandez, an associate professor at the University of Connecticut’s School of Pharmacy, and other authors of the meta-analysis are aware of the false information. The group released their study as a preprint before the journal published it. The first version included the false information. A corrected version properly portrayed the trial’s results for all-cause mortality in a figure summarizing the results, but still falsely said none of the trials showed a benefit against all-cause mortality.

Dr. Hernandez and Clinical Infectious Diseases did not respond to requests for comment.

The lingering false information is in a paper that has attracted numerous citations in other studies, in the press, and on social media. Altmetric, which tracks engagement, scores it at 5,900. A score of 20 or means a paper is doing “far better than most of its contemporaries,” according to the company.

Morimasa Yagisawa of Kitasato University and other researchers pointed out the issue in a March review of ivermectin trials, saying they were “concerned about the spread of misinformation and/or disinformation” about trial results.

“The articles on systematic reviews and meta-analyses are often erroneous or misleading. This is perhaps because the authors were not involved in the clinical trials or patient care and only searched for and analyzed articles and databases on clinical trial results,” they wrote. The problems are “particularly serious” in the paper for which Dr. Hernandez was the corresponding author, the researchers said.

“Although it was a clear error, the wrong content of the preprint was published as a major article in Clinical Infectious Diseases, the official journal of the Infectious Diseases Society of America, without being changed,” they wrote. “Many comments were made questioning the insight of the reviewers and the Editor-in-Chief for publishing a paper with such inconsistencies, but the paper is still published without correction. Since this is a prestigious journal of a prestigious society, an early corrective action is required.”

“There have been several fraudulent meta-analyses, and this is a striking one,” Dr. Pierre Kory, president and chief officer of the FLCCC Alliance and author of the book The War on Ivermectin, told The Epoch Times in an email.

“In this meta-analysis, they selected only 10 of the 81 controlled trials, 33 of which were randomized, on ivermectin that were available at the time. Eight of the ten they selected involved mild COVID-19. Typically, mild COVID does not lead to death. And here they were looking at death rates and, as expected, saw very few. The inclusion criteria they used were intended to show no effect. And they succeeded. Conflicted researchers have been doing this to hydroxychloroquine and ivermectin since the beginning of the pandemic,” he added.

Issues in other meta-analyses include the improper inclusion of papers that did not describe clinical trial results, Mr. Yagisawa and his co-authors said.

They noted that a number of trials have found ivermectin recipients were better off. That includes trials cited by the U.S. Food and Drug Administration (FDA) in its position that ivermectin is not effective against COVID-19.

The FDA recently settled a lawsuit over that position, agreeing to take down several web pages and social media posts.

https://www.zerohedge.com/political/popular-paper-ivermectin-and-covid-19-contains-false-information

Liquid Biopsy Has Near-Perfect Accuracy for Early Pancreatic Cancer

 A liquid biopsy assay that combines a microRNA signature and a well-known biomarker for pancreatic cancer has demonstrated an accuracy of 97% for detecting stage I/II pancreatic ductal adenocarcinoma, the most common type of pancreatic cancer.

It is quite encouraging to know we have a blood test that could potentially find this disease early, said Ajay Goel, PhD, a molecular diagnostics specialist at City of Hope in Duarte, California, who presented the findings at the American Association for Cancer Research (AACR) Annual Meeting 2024.

Goel and colleagues developed a signature for pancreatic cancer based on microRNAs identified in the exomes shed from pancreatic cancers and cell-free DNA markers found in the blood of patients with the disease.

Their initial assay tested blood samples for this signature in a training cohort of 252 people in Japan, approximately 60% of whom had pancreatic cancer. The rest were healthy controls. The assay was then tested in validation cohorts of 400 subjects, half with pancreatic cancer and half controls, in China and South Korea.

In both the initial and validation tests, the microRNA assay had an accuracy of about 90% for stage I/II pancreatic cancer, already far better than commercially available assays.

In an additional validation cohort in the United States with 139 patients with pancreatic cancer and 193 controls at six centers across the country, the researchers found that adding carbohydrate antigen 19-9 — a well-known marker of pancreatic cancer — to the assay boosted the test's accuracy to 97%.

The test performed the same whether the tumor was in the head or tail of the pancreas.

"We are very excited about this data," said Goel.

The technology was recently licensed to Pharus Diagnostics for commercial development, which will likely include a prospective screening trial, he told Medscape Medical News.

Because pancreatic cancer is fairly uncommon, Goel did not anticipate the test being used for general screening but rather for screening high-risk patients such as those with newly diagnosed type 2 diabetes, a family history of pancreatic cancer, or predisposing genetic mutations.

"It should be a very inexpensive test; it doesn't cost us much to do in the lab," he added.

Study moderator Ryan Corcoran, MD, PhD, a gastrointestinal (GI) oncologist at Massachusetts General Hospital, Boston, saw the potential.

"As a GI oncologist, I know how lethal and hard to treat pancreatic cancer is," he said. A test that could reliably detect pancreatic cancer early, with an acceptable false-positive rate, would be extremely useful.

"The cure rate is many, many times higher," if we detect it before it has a chance to spread, he explained.

In the meantime, Goel said there's more work to be done.

Almost 4000 subjects have been enrolled in ongoing validation efforts, and efforts are underway to use the test to screen thousands of banked blood samples from the PLCO, a prospective cancer screening trial in healthy subjects.

The researchers also want to see if the test can distinguish benign pancreatic cysts from ones that turn cancerous.

The idea is to find the earliest possible signs of this disease to see if we can find it not "at the moment of clinical diagnosis, but possibly 6 months, 1 year, 2 years earlier" than with radiologic imaging, Goel said.

The work was funded by the National Cancer Institute and others. Goel is a consultant for Pharus Diagnostics and Cellomics. Corcoran is a consultant for, has grants from, and/or holds stock in numerous companies, including Pfizer, Novartis, Eli Lilly, and Revolution Medicines.

https://www.medscape.com/viewarticle/liquid-biopsy-has-near-perfect-accuracy-early-pancreatic-2024a10006ut

Preventive PCI for Vulnerable Plaques Reduces Cardiac Events

 In patients with non–flow-limiting vulnerable plaques, percutaneous coronary intervention (PCI) plus optimal medical therapy reduced the risk for adverse cardiac events and death compared with optimal medical therapy alone.

"PREVENT is the first randomized trial of vulnerable plaque treatment that was powered for clinical events," coprincipal investigator Gregg W. Stone, MD, director of Academic Affairs for the Mount Sinai Heart Health System and a professor of cardiology and population health sciences and policy at the Icahn School of Medicine at Mount Sinai in New York City, told theheart.org | Medscape Cardiology in a preconference interview.

The previously reported PROSPECT ABSORB study, led by Stone, showed that such lesions could be safely treated with PCI, and "there were strong trends for reduced clinical events over time," he said. "But that trial was powered for safety, not clinical events."

The PREVENT trial findings "suggest that we may totally change the treatment paradigm for the types of lesions that should undergo revascularization," he said. Such lesions — most commonly, thin cap fibroatheromas — are often relatively mild and would not provoke ischemia or angina, so guidelines don't recommend treating them with PCI. "However, they're the kind of plaques that place patients at risk for an acute coronary syndrome or myocardial infarction (MI) or sudden cardiac death."

The PREVENT findings were presented on April 8 at the American College of Cardiology (ACC) Scientific Session 2024. The study was simultaneously published online in The Lancet.

Consistently Better Outcomes With PCI

The PREVENT trial was an open-­label randomized controlled trial conducted at 15 research hospitals in South Korea, Japan, Taiwan, and New Zealand.

Patients with non–flow-limiting (fractional flow reserve > 0-80) vulnerable coronary plaques were randomly assigned to either PCI plus optimal medical therapy or optimal medical therapy alone, stratified by diabetes status and the performance of PCI in a nonstudy target vessel.

After PCI, all patients received dual antiplatelet therapy for at least 6 or 12 months. Optimal medical therapy for both the groups included lifestyle modifications and intensive, guideline-directed medical therapy for secondary prevention. High-dose statin therapy was strongly recommended but was left at the discretion of local investigators.

Follow-up was done at 1, 6, 12, and 24 months after randomization and every year thereafter, until the last enrolled patient reached 2 years after randomization.

The primary outcome was target vessel failure: A composite of death from cardiac causes, target vessel MI, ischemia-driven target vessel revascularization, or hospitalization for unstable or progressive angina at 2 years.

Secondary outcomes were the individual components of the primary composite outcome, death from any cause, any MI, any revascularization, definite stent or scaffold thrombosis, stroke, bleeding events, angina status, procedural complications, and the patient­oriented composite of all-cause death, all MIs, or any repeat revascularization.

A total of1606 patients (median age, 65 years; 73% men) were randomly assigned (1:1) to PCI or optimal medical therapy alone.

Overall, 97% of patients (1556) completed the 2-year follow-up. The primary outcome occurred in three patients (0.4%) in the PCI group and in 27 patients (3%-4%) in the medical therapy group.

In the post hoc analysis, the composite rate of death from any cause or target vessel MI was consistently lower at 2 years with preventive PCI than with optimal medical therapy alone, as was the composite rate of death from cardiac causes or target vessel MI.

"Basically, we prevented every type of the component events — all of them were consistently reduced in the right direction," Stone said, "and there were no major safety concerns with this therapy."

Indeed, serious clinical or adverse events did not differ between the PCI and medical therapy groups: At 2 years, four (0.5%) vs 10 (1.3%) patients died and nine (1.1%) vs 13 (1.7%) had an MI.

In addition, the authors noted that in the post hoc as-­treated analysis, the durability of preventive PCI seemed to be more sustained with cobalt-chromium everolimus­-eluting metallic stents than with bioresorbable vascular scaffolds.

What's Ahead

"Given that PREVENT is the first large trial to show the potential effect of the focal treatment for vulnerable plaques, these findings support consideration to expand indications for percutaneous coronary intervention to include non–flow-limiting, high-risk vulnerable plaques," the authors wrote in The Lancet.

Seung-Jung Park, MD, professor in the Division of Cardiology at Asan Medical Center at the University of Ulsan College of Medicine in Seoul, Republic of Korea, who presented the findings said, "Further research is necessary to provide better identification of which patients or lesions can most benefit from invasive or noninvasive imaging evaluation for detection of vulnerable plaques, optimal risk-stratification, and the application of preventive PCI."

Stone noted that although the data from this study are "pretty strong," he would like to see a confirmatory study before recommending that clinicians start performing preventive PI for vulnerable lesions. "But I think it is a therapy that could be considered in select situations, after an informed discussion with the patient."

In a linked comment, Josip A. Borovac, MD, of the University of Split School of Medicine, Split, Croatia, concluded that "the primary value of the PREVENT trial lies in its identification of a crucial subset of patients, primarily in the context of stable angina, who would have substantial mortality and morbidity benefits with preventive percutaneous coronary intervention compared with optimal medical therapy alone." 

"This discovery will have important clinical implications for the future management of these patients in contemporary clinical practice."

The study was funded by the Cardiovascular Research Foundation, Abbott, Yuhan Corp, CAH-Cordis, Philips, and Infraredx (a Nipro company). Park reported research grants and speaker fees from Abbott Vascular, Medtronic, Daiichi-Sankyo, Chong Kun Dang Pharm, Daewoong Pharma, and Edwards. Stone reported fees from multiple pharmaceutical and biotech companies. Borovac declared no competing interests.

https://www.medscape.com/viewarticle/preventive-pci-vulnerable-plaques-reduces-cardiac-events-2024a10006tc

Vera Therapeutics Shares Rise 9.9% After Alpine Acquisition

Shares of Vera Therapeutics were up late Wednesday after Alpine Immune Sciences, whose lead candidate is similar to Vera's, said it would be acquired at a premium.

Vera stock was up 9.9% to $45.74 in late trading, after rising 9.8% in the regular session on earlier reports of the deal. Shares have more than doubled this year as of Wednesday's close.

Alpine agreed to be acquired by Vertex Pharmaceutical for about $4.9 billion in cash, or $65 a share, representing a premium of about 67% on Alpine's unaffected share price before rumors of the deal.

Alpine's lead candidate, povetacicept, is a potential treatment for IgA nephropathy, a kidney condition.

Vera's lead candidate, atacicept, is being evaluated as a treatment for various autoimmune diseases, including IgA nephropathy.

The two treatments use similar mechanisms, blocking B-cell Activating Factor and A PRoliferation-Inducing Ligand, both types of proteins.

https://www.marketscreener.com/quote/stock/VERA-THERAPEUTICS-INC-122751368/news/Vera-Therapeutics-Shares-Rise-9-9-After-Alpine-Acquisition-46409089/

Nearly half of UK companies still plan price increases, survey shows

 Almost half British firms plan to raise their prices over the coming year as they struggle with high wage bills, according to a survey that underscored why the Bank of England is cautious about cutting interest rates.

The British Chambers of Commerce said 46% of its member companies expected to raise prices over the next 12 months, down only slightly from 47% in its previous quarterly survey published in January.

Only 3% of respondents expected to cut prices while 51% saw no change.

Staffing costs represented the main pressure on firms as a nearly 10% increase in the minimum wage came into force on April 1.

"The recent rise in the national living wage is good news for millions of employees," Shevaun Haviland, the BCC's director general, said. "But it comes at a time when labour costs pressures for business are already very high."

David Bharier, head of research at the BCC, said the pricing expectations also reflected conflicts around the world and the costs of Britain's plan to introduce more post-Brexit checks on imports from the European Union later this month.

The BoE has said the surge in wage growth last year is likely to fade only slowly, even with headline price growth now close to its 2% target.

The BCC survey showed 56% of respondents expected turnover to grow over the next 12 months, unchanged from the previous survey three months ago.

There was no overall improvement in business conditions as measured by investment, sales and cashflow, the BCC said.

The BCC survey, Britain's longest-running private-sector business survey, was based on responses from 4,800 companies - 92% of them with under 250 employees - polled between Feb. 12 and March 12.

https://www.marketscreener.com/quote/currency/EURO-BRITISH-POUND-EUR-GB-4593/news/Nearly-half-of-UK-companies-still-plan-price-increases-survey-shows-46408875/

Biggest Corporate Welfare Scam Of All Time

 by Stephen Moore via The Epoch Times,

President Joe Biden keeps lecturing corporate America to “pay your fair share” of taxes.

It turns out he’s right that some companies really are getting away scot-free from paying taxes.

But it isn’t Big Tech companies in Silicon Valley or the Wall Street financial company “fat cats” or big banks or Walmart.

They pay billions in taxes.

The culprits here are the very companies that President Biden is in bed with: green energy firms.

It turns out that despite all the promises over the past decade about how renewable energy is the future of power production in America, by far the biggest tax dodgers in the country are the wind and solar power industries.

Over the past several decades, the green energy lobby—what I call the climate-change-industrial complex—isn’t paying its fair share. That’s because the vast majority of these companies pay nearly ZERO income taxes.

But they wade in rivers of federal direct and indirect subsidies that keep these zombie companies alive. Over the past two decades, the renewable energy lobby has collected more than one-quarter trillion dollars in subsidies—payments that we’ve been assured over and over would be temporary. The argument for these grants, loans, tax abatements and other sweetheart kisses is that these were “infant industries” in need of a Head Start program for CEOs.

Except these companies have never even reached puberty after all these years.

What’s worse is that President Biden keeps spoiling the children with lavish gifts for bad performance.

A new report by tax expert Adam Michel at the Cato Institute finds the green energy subsidies—mostly created by Biden policies like the so-called Inflation Reduction Act—will drain the Treasury of as much as $1.8 trillion over 10 years.

The Cato report finds that since its passage, “the estimated cost of the IRA’s new and expanded energy tax credits increased dramatically.”

These tax shelters are just a form of Aid to Dependent Corporations. They never seem to want to cut the umbilical cord.

What have we gotten for this mountain of taxpayer-funded green energy largesse?

Nothing, really.

Today, we still get 80 percent of our energy in America from fossil fuels and nuclear power. Wind and solar are stuck at less than 10 percent. This is some investment we’re making.

Meanwhile, President Biden keeps railing against companies that pay no income tax. He’s advocated a mandatory 15 percent minimum corporate tax. But guess what industry is explicitly exempt from the minimum? The green energy lobby.

It’s just a reminder that a lot of people are getting really, really rich off climate change hysteria.

The “green” in green energy doesn’t stand for a cleaner environment.

It stands for the color of money. Yours and mine.

https://www.zerohedge.com/political/biggest-corporate-welfare-scam-all-time

CDC Hid Finding Of Possible Link Between COVID Vaccines and Tinnitus

 by Zachary Stieber via The Epoch Times (emphasis ours),

The U.S. Centers for Disease Control and Prevention (CDC) and its partners uncovered signs that the Pfizer-BioNTech and Moderna COVID-19 vaccines might cause the persistent condition called tinnitus but never disclosed the findings to the public, The Epoch Times can report.

The signs were found while analyzing data from the CDC’s Vaccine Safety Datalink (VSD), which has been described as one of the stronger CDC surveillance systems because it utilizes health care records.

The detection of the signs came just after the CDC told a reporter that there were no signs of large numbers of cases of tinnitus, which commonly manifests as a constant ringing in the head, following COVID-19 vaccination, documents obtained by The Epoch Times show.

The CDC never updated the reporter, whose story reported that the CDC had not found a clustering of cases.

The CDC declined to comment.

The documents “prove that they were aware of a safety signal of tinnitus after the COVID-19 shots as early as 2022,” Dr. Joel Wallskog, co-chair of the advocacy group React19, told The Epoch Times via email. “However, to my knowledge, this safety signal was never communicated to the public and no further epidemiological study on tinnitus in VSD was ever completed.”

The Epoch Times obtained the documents through a Freedom of Information Act (FOIA) request.

Previous requests have yielded other evidence the CDC knew about possible safety problems with the COVID-19 vaccines but did not alert the public. That includes the detection in May 2022 of a safety signal for tinnitus and the Pfizer and Moderna vaccines, in an analysis of data from another CDC system, which is based on reports filed by doctors and others.

“As time passes and more FOIA requests are executed, how many more safety signals will we learn about that the CDC knew about years ago? When does this nightmare end? When will the American public know the whole truth and nothing but the truth? Is the CDC evil or incompetent? Or maybe both,” Dr. Wallskog added.

Detection

A CDC spokeswoman, according to one of the emails obtained by The Epoch Times, told a reporter on Sept. 21, 2022, that the CDC was aware of reports of tinnitus after COVID-19 vaccination lodged with the Vaccine Adverse Event Reporting System (VAERS). That CDC-run system accepts reports from anybody, although most are filed by health care workers.

“Because so many people have been vaccinated, and because tinnitus is so common in the population, temporally-associated cases are expected, with some expected to occur shortly after vaccination,” Martha Sharan, the spokeswoman, said.

The CDC opted to explore potential links in VSD.

“Unlike VAERS, which relies primarily on voluntary reports ... the VSD uses data from electronic health records,” Ms. Sharan said. “Consequently, the VSD data are less likely to be affected by the reporting biases and other biases that impact spontaneous reporting patterns to VAERS and data quality.”

The analysis of VSD data showed that “to date, no clustering of tinnitus diagnoses have been observed post-vaccination,” she added.

Katherine Yih, PhD, leads analyses of VSD data to monitor vaccine safety. She’s an assistant professor at the Harvard Pilgrim Health Care Institute’s Department of Population Medicine and receives funding from the CDC.

Ms. Yih informed CDC officials on Sept. 29, 2022, that analyses of VSD data turned up “statistically significant temporal clusters” for tinnitus following receipt of the Pfizer and Moderna vaccines, another email obtained by The Epoch Times shows. Both vaccines utilize messenger RNA (mRNA) technology.

“Both strongest clusters for the mRNA vaccines start around 12-13 days after when dose 2 would likely have been received,” she said. “The relative risks are quite low and certainly it’s hard to see anything on visual inspection of the graphs, especially for Moderna, so this seems to be a subtle effect if it is truly a VAE, unless you’re one of the unlucky ones who got tinnitus.”

VAE stands for vaccine adverse event.

Ms. Yih told the officials they could discuss the matter during an upcoming call.

See the emails here...

No Disclosure

Tara Haelle, the reporter who contacted the CDC about VSD and tinnitus, asked for an interview with one of the officials, Dr. Tom Shimabukuro, in August 2022, after a study found “overwhelming statistical support in VAERS” for tinnitus being a possible side effect of the mRNA shots.

Ms. Sharan informed Ms. Haelle that the VSD analysis did not show any clustering of tinnitus after COVID-19 vaccination. In a follow-up email on Sept. 29, 2022, attributed to Dr. Shimabukuro, he repeated the statement.

Hours later, Ms. Yih alerted Dr. Shimabukuro and others to the clustering that was found.

The CDC appears to have never alerted Ms. Haelle, or the general public, to the discovery.

Dr. Shimabukuro wanted to delay the interview, Ms. Sharan added soon after, because the CDC was going to conduct additional analyses of VSD data. The analyses would be done “relatively soon,” according to Dr. Shimabukuro.

On Nov. 10, 2022, Ms. Sharan told Ms. Haelle that “vaccine safety monitoring efforts in CDC have identified no evidence of a causal association between COVID-19 vaccination and tinnitus or other hearing loss,” conveying a statement from Dr. John Su, another CDC official, and that the VSD analysis was “in progress.”

On Dec. 19, 2022, Ms. Yih sent an “outline of tinnitus exploration” to Dr. Shimabukuro and other officials. The “outline for a possible report on COVID vaccination and tinnitus” was created at the request of one of the other officials, she said. Large portions of that and other emails were redacted.

On Dec. 16, 2022, results from analyses of the VSD data were published. The study, co-authored by Ms. Yih and others, did not mention tinnitus. Ms. Yih did not respond to a request for comment.

On Jan. 8, 2023, Ms. Sharan told Ms. Haelle that the CDC “doesn’t have enough evidence to justify an epidemiologic study on tinnitus in VSD.”

Despite Ms. Haelle’s efforts, the CDC refused to provide the results of its analyses.

Ms. Haelle’s article was published on Feb. 21, 2023. Ms. Haelle, who did not respond to an inquiry, wrote that the CDC said it “found no evidence that tinnitus diagnoses were clustered together following vaccination but hasn’t published that analysis and declined to share the preliminary report.”

“If the CDC had found a statistically significant link to tinnitus, it could have taken steps to add an official warning to the vaccine labels,” she added later.

Other Countries Find Link

Other researchers and countries have identified a link between tinnitus and COVID-19 vaccines.

U.S. researchers, for example, said in early 2022 that VAERS data “suggest an association” between the vaccines and tinnitus.

Australian and South Korean researchers later reported finding that vaccinated people faced an increased risk of tinnitus, including people who received a Moderna or Pfizer vaccine.

Some other papers, on the other hand, such as one from the United States, have not found an increase in tinnitus after COVID-19 vaccination.

Due to increasing evidence of a link, the European Medicines Agency added tinnitus to the labels for the AstraZeneca and Johnson & Johnson COVID-19 vaccines. Tinnitus may affect up to one in 1,000 people after the shots, according to the agency.

Australian regulators have also placed tinnitus on the labels for the AstraZeneca and Novavax COVID-19 vaccines. The AstraZeneca shot has never been authorized in the United States.

The method by which the vaccines may cause the condition remains unconfirmed.

Drs. Christian Rausch and Qun-Ying Yue of the Uppsala Monitoring Centre have proposed that the vestibulocochlear nerve may be involved. Others have postulated inflammation being the culprit. Treatments include ivermectin and ganglion blocks.

https://www.zerohedge.com/political/cdc-hid-finding-possible-link-between-covid-vaccines-and-tinnitus