'Statistically Significant Increase' In Myopericarditis, Single Organ Cutaneous Vasculitis After COVID Vax

  by Megan Redshaw via The Epoch Times (emphasis ours),

A large nationwide study of more than 4 million people in New Zealand identified a statistically significant association in two adverse events following vaccination with Pfizer’s COVID-19 vaccine.

In the post-marketing safety study recently published in Springer, researchers examining 12 specific adverse events found an increase in myopericarditis during the 21-day period following both Pfizer vaccine doses. Myopericarditis describes two distinct inflammatory heart conditions that occur simultaneously, myocarditis and pericarditis.

The highest rate of myopericarditis was observed in the youngest participants under 39 years of age following the second vaccine dose—with an estimated five additional myopericarditis cases per 100,000 persons vaccinated regardless of age. Researchers also observed an increase following both vaccine doses in individuals aged 40 to 59.

“Our findings align with international postmarketing studies, case series reports, and cases detected through reports to New Zealand’s spontaneous system that identify an association between the BNT162b2 vaccine and myo/pericarditis, especially in younger people and after the second dose,” the researchers stated.

In addition to myopericarditis, the study found an increase in single-organ cutaneous vasculitis (SOCV) in the 20- to 39-year-old age group following the first vaccine dose. SOCV is a syndrome characterized by inflammation and damage to the skin's blood vessels without the involvement of other organ systems.

Study Methods

To carry out their study, researchers collected data from Feb. 19, 2021, at the beginning of the vaccine rollout, to Feb. 10, 2022, among 4,114,364 individuals aged 5 and older who received a first and second primary or pediatric dose of Pfizer’s COVID-19 vaccine. During the study period, 13,597 individuals were excluded after testing positive for COVID-19.

The researchers then compared the incidence rates of each outcome of interest for 21 days—the interval between first and second vaccine doses—following vaccination with Pfizer’s COVID-19 vaccine to the expected background incidence rate from a pre-vaccination period (2014 to 2019) to detect vaccine safety signals.

Outcomes of interest were identified from New Zealand’s National Minimum Data Set—a national data collection system for all public hospitalizations connected to a National Health Index number that allows researchers to link hospitalization with Pfizer vaccination records in the National COVID Immunisation Register.

The 12 adverse events analyzed included acute kidney injury, acute liver injury, Guillain-Barré syndrome, erythema multiforme, herpes zoster, SOCV, myopericarditis (includes all events coded as myocarditis, pericarditis, and myopericarditis), arterial thrombosis, cerebral venous thrombosis, splanchnic thrombosis, venous thromboembolism, and thrombocytopenia.

Outside of myopericarditis and SOCV, researchers identified no other statistically significant associations between Pfizer’s COVID-19 vaccine and other outcomes of interest for all ages combined. Unlike myopericarditis, SOCV has not been identified as an adverse reaction to Pfizer’s COVID-19 vaccine, and only a few case reports and reviews have been published in the literature.

Potential Study Limitations

The study had several potential limitations. Although many adverse events of special interest resulted in hospitalization, some conditions, such as herpes zoster, are typically treated in the primary care setting. Diagnoses of conditions following COVID-19 vaccination in the general setting were not included in the analysis and could be underestimated.

Using ICD-10-AM codes to identify outcomes of interest without conducting clinical record assessments could lead to potential misclassification, and changing diagnostic codes before the study period could overinflate or underestimate potential adverse events.

Healthy vaccinee bias could affect results when comparing observed adverse events among the vaccinated cohort with the background population, as healthier people are more likely to get vaccinated. Additionally, a risk period of one to 21 days may exclude potential adverse events beyond the time frame, according to the study.

Researchers Conclude Benefits of Vaccines Still Outweigh Risks

Despite the increased risk of myopericarditis observed during the study, researchers said the risk of myocarditis following SARS-CoV-2 infection is “substantially greater” than after COVID-19 mRNA vaccination, leading them to conclude the benefits of vaccination still outweigh the risks from the disease.

Yet experts acknowledge that myocarditis caused by a natural viral infection differs from that triggered by mRNA COVID-19 vaccination. As previously reported by The Epoch Times, although COVID-19 can cause myocarditis, the myocarditis developed by a healthy young person post-infection is extremely mild compared to the onset of myocarditis following COVID-19 vaccination.

According to pediatric cardiologist Dr. Kirk Milhoan, myocarditis caused by the COVID-19 vaccine differs from viral myocarditis because an infection of the heart isn't causing the damage. It's being damaged by the "spike protein that's cardiotoxic to the heart," which causes inflammation in the three main vessels of the heart by a different process.

"There’s a difference between the body encountering a virus naturally that causes myocarditis and actively giving the body something we know causes harm," Dr. Milhoan told The Epoch Times.

The New Zealand study adds to a growing body of evidence showing mRNA COVID-19 vaccination can trigger heart inflammatory conditions in young people.

https://www.zerohedge.com/political/statistically-significant-increase-myopericarditis-and-single-organ-cutaneous-vasculitis

Mount Sinai to close Beth Israel campus in New York

 New York City-based Mount Sinai Health is to close its Beth Israel campus in the city "after years of agonizing debate and analysis" and could open a smaller facility downtown in the future.

The closure will be gradual after an initial reduction of the inpatient bed count at the 696-bed teaching hospital, with the eventual shuttering expected to take a few years.

"We will remain open with a smaller bed count as we work with regulators to gradually close the 16th St. campus at MSBI and continue to evaluate various options for a smaller hospital nearby," according to a news release provided to Becker's.

Mount Sinai will offer affected unionized employees similar roles within the system.

The hospital will close despite "massive investments and upgrades" within the past 10 years. Escalating losses, with a further $150 million expected this year, and chronic underutilization with inpatient use typically at only 20 percent of capacity, have forced the issue.

"Maintaining the status quo is no longer an option," according to the news release. "As a leading non-profit institution, we must take immediate steps to preserve our ability to continue providing healthcare services to the greater New York City community."

While the hospital gradually closes, Mount Sinai Beth Israel will continue to maintain a presence in downtown New York with its new $140 million behavioral health center and other facilities.

"While we will never abandon the downtown community, continuing to keep the MSBI 16th St. hospital open would jeopardize the mission of the Mount Sinai Health System," the release concluded.

https://www.beckershospitalreview.com/finance/mount-sinai-to-close-beth-israel-campus-in-new-york.html

New Antibiotic Could Combat Multidrug-Resistant Superbugs

 Antibiotic resistance is a major public health problem. Few new molecules are in development, but a new antibiotic called clovibactin brings hope.

This drug, isolated from bacteria that haven't previously been studied, seems to be capable of combating multidrug-resistant "superbugs" thanks to unusual mechanisms of action.

The drug was discovered and has been studied by scientists from Utrecht University in the Netherlands, the University of Bonn in Germany, the German Center for Infection Research, Northeastern University in Boston, and NovoBiotic Pharmaceuticals in Cambridge, Massachusetts.

Their research was published in Cell.

"Since clovibactin was isolated from bacteria that could not be grown before, pathogenic bacteria have not seen such an antibiotic before and had no time to develop resistance," said Markus Weingarth, MD, PhD, researcher in Utrecht University's chemistry department, in a press release.

Microbial "Dark Matter"

Researchers isolated clovibactin from sandy soil from North Carolina and studied it using the iCHip device, which was developed in 2015. This technique allowed them to grow "bacterial dark matter," so-called unculturable bacteria, which compose a group to which 99% of bacteria belong.

This device also paved the way for the discovery of the antibiotic teixobactin in 2020. Teixobactin is effective against gram-positive bacteria and is one of the first truly new antibiotics in decades. Its mechanism of action is like that of clovibactin.

Combats Resistant Bacteria

In the Cell article, the researchers showed that clovibactin acts via several mechanisms and that it successfully treated mice infected with the superbug Staphylococcus aureus.

Clovibactin exhibited antibacterial activity against a broad range of gram-positive pathogens, including methicillin-resistant S aureus, daptomycin-resistant and vancomycin-resistant S aureus strains, and difficult-to-treat vancomycin-resistant Enterococcus faecalis and E faecium (vancomycin-resistant enterococci). Escherichia coli was only marginally affected "compared with an outer membrane deficient E coli WO153 strain, probably reflecting insufficient penetration of the compound," the authors write.

Original Mechanism of Action

Clovibactin acts not on one but three molecules, all of which are essential to the construction of bacterial walls: C55PP, lipid II, and lipid IIIWTA, which are from different cell wall biosynthetic pathways. Clovibactin binds to the pyrophosphate portion of these precursors.

"Clovibactin wraps around the pyrophosphate like [a] tight glove, like a cage that encloses its target," said Weingarth. This is what gives clovibactin its name, which is derived from Greek word klouvi, meaning cage.

The remarkable aspect of clovibactin's mechanism is that it only binds to the immutable pyrophosphate that is common to cell wall precursors, but it also ignores the variable sugar-peptide part of the targets. The bacteria therefore has a much harder time developing resistance against it. "In fact, we did not observe any resistance to clovibactin in our studies," Weingarth confirmed.

Upon binding the target molecules, it self-assembles into large fibrils on the surface of bacterial membranes. These fibrils are stable for a long time and thereby ensure that the target molecules remain sequestered for as long as necessary to kill bacteria.

Few Side Effects

Because of the mechanism of action of the antibiotic, few side effects are predicted. Indeed, clovibactin targets bacteria cells but not human cells.

"Since these fibrils only form on bacterial membranes and not on human membranes, they are presumably also the reason why clovibactin selectively damages bacterial cells but is not toxic to human cells," said Weingarth.

Other studies ― in particular, studies in humans ― are needed before the antibiotic can be considered a potential treatment. In the meantime, regulations regarding the proper use of antibiotics must continue to be applied to limit antibiotic resistance.

In 2019, 4.95 million deaths worldwide were associated with bacterial antimicrobial resistance, including 1.27 million deaths directly attributable to bacterial antimicrobial resistance. If this trend continues without new medicines becoming available to treat bacterial infections, it is estimated that by 2050, 10 million people will die every year from antimicrobial drug resistance.

https://www.medscape.com/viewarticle/996504

Ascendis: German Launch of Growth Hormone Deficiency Treatment

 Ascendis Pharma, Inc.  (Nasdaq: ASND) today announced the launch in Germany of SKYTROFA^® (lonapegsomatropin), its growth hormone approved in the European Union for the once-weekly treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient endogenous growth hormone secretion (growth hormone deficiency, or GHD).

https://finance.yahoo.com/news/ascendis-pharma-launches-skytrofa-lonapegsomatropin-120000039.html

NeuroBo Starts Phase 2a Clinical Trial Evaluating DA-1241 for Treatment of NASH

 NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced dosing of the first patient in its two-part, Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, for the treatment of nonalcoholic steatohepatitis (NASH), at The Pinnacle Edinberg/South Texas Research Institute in Edinburg, Texas, under the supervision of Principal Investigator, Dr. David Ramirez.

https://www.biospace.com/article/releases/neurobo-pharmaceuticals-doses-first-patient-in-its-phase-2a-clinical-trial-evaluating-da-1241-for-the-treatment-of-nash/

No 'Silver Bullet' for Generic Drug Shortage, House Members Told

 From the beginning of Thursday's House hearing

opens in a new tab or window on ways to solve the generic drug shortage, it appeared obvious that little agreement was going to be reached on the best solutions to the problem.

"After months of pleading by the Democratic members of this subcommittee, we're finally having a legislative hearing on drug shortages in our country," Rep. Anna Eshoo (D-Calif.), ranking member of the House Energy & Commerce Health Subcommittee, said in her opening statement. "I've been frustrated by our subcommittee's inaction through the spring and summer as I heard from so many physicians in my congressional district, and read about cancer patients, especially children, left behind due to shortages in life-saving treatments."

Eshoo was especially critical of a "discussion draft" of legislation known as the Stop Drug Shortages Act

opens in a new tab or window sponsored by Rep. Cathy McMorris Rodgers (R-Wash.), chair of the full Energy & Commerce Committee. "This proposal mostly studies the problem with more reports," she said. "Where the proposal has actionable policy, I think it's a grab bag of talking points ... The [bill's] proposed inflation rebate policy misunderstands the market failure that caused drug shortages."

McMorris Rodgers defended the bill. "The discussion draft focuses primarily on generic, sterile, and injectable drugs for a serious disease or condition and getting these drugs out from under mandatory 340B [drug discount program] rebates and inflation penalties," she said, referring to the 340B drug discount program for hospitals that serve a large proportion of uninsured and underinsured patients. "We require CMS to launch a model that tests market-based pricing policies for these drugs in Medicare as well. The discussion draft also looks into how we can bring transparency to current contracting practices through new 340B guidance and disclosure reporting for group purchasing organizations."

Subcommittee chair Brett Guthrie (R-Ky.) summarized the extent of the problem. "In 2022 alone, there were 301 drugs in active shortage, according to the University of Utah," he said. "For over a decade, professionals in the medical and regulatory community have sounded the alarm on the underlying economic causes of drug shortages."

"Unforeseen circumstances like a tornado hitting a pharmaceutical warehouse in North Carolina, or a manufacturing facility in India shutting down due to quality concerns, can throw a supply chain out of whack and potentially cause a shortage of vital drugs," he continued. "To ensure we're prepared to respond appropriately to these issues, we must encourage strong investments to ensure that there are multiple means to develop, store, and distribute drugs."

Rep. Frank Pallone (D-N.J.), ranking member of the full Energy & Commerce Committee, stressed the need for immediate action. "Experts, including doctors providing care on the front line, told us drug shortages are an ongoing emergency for their patients and a threat to national security," he said. "Patients and providers are facing life-altering consequences if we don't do more to address this critical problem."

In addition to McMorris Rodgers's bill, the committee was considering several other bills to address the problem, including:

• The Drug Shortage Prevention Act, which would require manufacturers to notify the FDA of a permanent discontinuance or interruption in the manufacture of an excipient (inactive) ingredient or active pharmaceutical ingredient (API) that is likely to result in meaningful disruption in supply. The bill would require the FDA to issue guidance on such notifications no later than 6 months after the enactment of the bill.
• The Ensuring Access to Lifesaving Drugs Act, which would require manufacturers of life-saving drugs to submit expiration and stability testing studies and make labeling changes accordingly; the measure aims to allow manufacturers to extend expiration dates for drugs if it can be done safely.
• The Patient Access to Urgent-Use Pharmacy Compounding Act, which would allow certain facilities to compound drugs when a licensed prescriber certifies to the pharmacist that such prescriber has made reasonable attempts to obtain, but has not been able to obtain, a drug to address an urgent medical need.

Melissa Barber, PhD, postdoctoral fellow at the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, explained what is generally known about the shortage issue. "First, some types of products, particularly generic style injectables, are in short supply more often than others," she said. "Second, while any shortage is important to patients, not all shortages are equal in terms of public health importance. Third, we know that markets for some products are highly concentrated. [A] 2023 study found that approximately one-third of generic APIs produced for use in U.S. markets were manufactured by a single facility."

However, much is not known, she continued. "First, we don't even know the cause of most shortages that are reported. As of June 2023, 59% of reported shortages in the FDA's database did not have a declared cause because manufacturers are not obligated to give detailed information, nor does the FDA audit data to ensure accuracy ... Second, we don't know how many manufacturers there are globally for a given drug, where they are, or how much manufacturing capacity they have."

While there is "no single silver bullet" to fix the problem, "as a first step, the Agency Drug Shortages Task Force previously launched by the FDA should be reconvened as a single point of responsibility," Barber said. "At the very least, federal agencies can coordinate efforts."

If the problem isn't solved soon, the entire generic industry is at risk, said David Gaugh, RPh, interim president and CEO of the Association for Accessible Medicines, which represents generic drug manufacturers. "Unless Congress acts to address these issues today, business practices by middlemen such as group purchasing organizations, wholesalers, pharmacy benefit managers, and health plans are disrupting the economic sustainability of generic manufacturing, shrinking product portfolios, and reducing the availability of resources to counter drug shortages," he said, noting that nine out of every 10 prescriptions are for generic drugs.

Gaugh recommended that Congress take several steps to mitigate the problem, including exempting low-cost generics from the 340B program and ensuring that Medicare drug plans cover and encourage the use of new generics and biosimilars.

https://www.medpagetoday.com/publichealthpolicy/healthpolicy/106345

As More Patients Email Doctors, More Health Systems Start Charging Fees

 Meg Bakewell, who has cancer and cancer-related heart disease, sometimes emails her primary care physician, oncologist, and cardiologist asking them for medical advice when she experiences urgent symptoms such as pain or shortness of breath.

But she was a little surprised when, for the first time, she got a bill — a $13 copay — for an emailed consultation she had with her primary care doctor at University of Michigan Health. The health system had begun charging in 2020 for “e-visits” through its MyChart portal. Even though her out-of-pocket cost on the $37 charge was small, now she’s worried about how much she’ll have to pay for future e-visits, which help her decide whether she needs to see one of her doctors in person. Her standard copay for an office visit is $25.

“If I send a message to all three doctors, that could be three copays, or $75,” said Bakewell, a University of Michigan teaching consultant who lives in Ypsilanti, Michigan, and is on long-term disability leave. “It’s the vagueness of the whole thing. You don’t know if you’ll get into a copay or not. It just makes me hesitate.”

Spurred by the sharp rise in email messaging during the covid pandemic, a growing number of health systems around the country have started charging patients when physicians and other clinicians send replies to their messages. Health systems that have adopted billing for some e-visits include a number of the nation’s premier medical institutions: Cleveland Clinic, Mayo Clinic, San Francisco-based UCSF Health, Vanderbilt Health, St. Louis-based BJC HealthCare, Chicago-based Northwestern Medicine, and the U.S. Department of Veterans Affairs.

Billing for e-visits, however, raises knotty questions about the balance between fairly compensating providers for their time and enhancing patients’ access to care. Physicians and patient advocates fret particularly about the potential financial impact on lower-income people and those whose health conditions make it hard for them to see providers in person or talk to them on the phone or through video.

A large part of the motivation for the billing is to reduce the messaging. Soon after the pandemic hit, health systems saw a 50% increase in emails from patients, with primary care physicians facing the biggest burden, said A Jay Holmgren, an assistant professor of health informatics at UCSF, the University of California-San Francisco. System executives sought to compensate doctors and other providers for the extensive time they were spending answering emails, while prodding patients to think more carefully about whether an in-person visit might be more appropriate than a lengthy message.

After UCSF started charging in November 2021, the rate of patient messaging dipped slightly, by about 2%, Holmgren and his colleagues found.

Like UCSF, many other health systems now charge fees when doctors or other clinicians respond to patient messages that take five minutes or more of the provider’s time over a seven-day period and require medical expertise. They use three billing codes for e-visits, implemented in 2020 by the federal Centers for Medicare & Medicaid Services.

E-visits that are eligible for billing include those relating to changes in medication, new symptoms, changes or checkups related to a long-term condition, and requests to complete medical forms. There’s no charge for messages about appointment scheduling, prescription refills, or other routine matters that don’t require medical expertise.

So far, UCSF patients are being billed for only 2% to 3% of eligible e-visits, at least partly because it takes clinicians extra time and effort to figure out whether an email encounter qualifies for billing, Holmgren said.

At Cleveland Clinic, only 1.8% of eligible email visits are being billed to patients, said Eric Boose, the system’s associate chief medical information officer. There are three billing rates based on the time the clinician takes to prepare the message — five to 10 minutes, 11 to 20 minutes, and 21 minutes or more. He said patients haven’t complained about the new billing policy, which started last November, and that they’ve become “a little smarter and more succinct” in their messages, rather than sending multiple messages a week.

The doctors at Cleveland Clinic, like those at most health systems that bill for e-visits, don’t personally pocket the payments. Instead, they get productivity credits, which theoretically enables them to reduce their hours seeing patients in the office.

“Most of our physicians said it’s about time we’re getting compensated for our time in messaging,” Boose said. “We’re hoping this helps them feel less stressed and burned out, and that they can get home to their families earlier.”

“It’s been a frustration for many physicians for many years that we weren’t reimbursed for our ‘pajama-time’ work,” said Sterling Ransone, the chair of the American Academy of Family Physicians’ Board of Directors. Ransone’s employer, Riverside Health System in Virginia, started billing for e-visits in 2020. “We do it because it’s the right thing for patients. But rarely do you see other professions do all this online work for free,” he said.

“We see physicians working two to four hours every evening on their patient emails after their shift is over, and that’s not sustainable,” said CT Lin, the chief medical information officer at University of Colorado Health, which has not yet adopted billing for email visits. “But we worry that patients with complex disease will stop messaging us entirely because of this copay risk.”

Many health care professionals share the fear that billing for messages will adversely affect medically and socially vulnerable patients. Even a relatively small copay could discourage patients from emailing their clinicians for medical advice in appropriate situations, said Caitlin Donovan, a senior director at the National Patient Advocate Foundation, citing studies showing the dramatic negative impact of copays on medication adherence.

Holmgren said that while patients with minor acute conditions may not mind paying for an email visit rather than coming into the office, the new billing policies could dissuade patients with serious chronic conditions from messaging their doctors. “We don’t know who is negatively affected,” he said. “Are we discouraging high-value messages that produce a lot of health gains? That is a serious concern.”

Due to this worry, Lin said, University of Colorado Health is experimenting with an alternative way of easing the time burden of e-visits on physicians. Working with Epic, the dominant electronic health record vendor, it will have an artificial intelligence chatbot draft email replies to patient messages. The chatbot’s draft message will then be edited by the provider. Several other health systems are already using the tool.

There also are questions about price transparency — whether patients can know when and how much they’ll have to pay for an email visit, especially since much depends on their health plan’s deductibles and copays.

While Medicare, Medicaid, and most private health plans cover email visits, not all do, experts say. Coverage may depend on the contract between a health system and an insurer. Ransone said Elevance Health, a Blue Cross Blue Shield carrier, recently told his health system it would no longer pay for email or telephonic visits in its commercial or Medicaid plans in Virginia. An Elevance spokesperson declined to comment.

Another price concern is that patients who are uninsured or have high-deductible plans may face the full cost of an email visit, which could run as high as $160.

At University of Michigan Health, where Bakewell receives her care, patients receive a portal alert prior to sending a message that there may be a charge; they must click a box indicating they understand, said spokesperson Mary Masson.

But Donovan said that leaves a lot of room for uncertainty. “How is the patient supposed to know whether something will take five minutes?” Donovan said. “And knowing what you’ll be charged is impossible because of health plan design. Just saying patients could be charged is not providing transparency.”

https://kffhealthnews.org/news/article/email-doctor-visits-new-fees-copays/