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Monday, January 23, 2023

Egg prices rose 60% in 2022. One farm group claims ‘collusive scheme’ by suppliers

 Egg prices soared to historically high levels in 2022 — and one group is alleging the trend is due to something more nefarious than simple economics.

Across all egg types, consumers saw average prices jump 60% last year — among the largest percentage increases of any U.S. good or service, according to the consumer price index, an inflation measure.

Large, Grade A eggs cost $4.25 a dozen in December, on average — a 138% increase from $1.79 a year earlier, according to U.S. Bureau of Labor Statistics data.

The industry narrative has largely focused on a historic outbreak of avian influenza — which has killed tens of millions of egg-laying hens — as the primary driver of those higher prices.

But Farm Action, a farmer-led advocacy group, claims the “real culprit” is a “collusive scheme” among major egg producers to fix and gouge prices, the group said in a letter to the Federal Trade Commission.

Doing so has helped producers “extract egregious profits reaching as high as 40%,” according to the letter, issued Thursday, which asks FTC Chair Lina Khan to investigate for potential profiteering and “foul play.”

An FTC spokesman declined to comment due to a general agency policy regarding letters, petitions or complaints received from third parties.

However, food economists are skeptical an inquiry would uncover wrongdoing.

“I don’t think we’ve seen anything that makes us think that there’s something there other than normal economics happening right now,” said Amy Smith, vice president at Advanced Economic Solutions.

“I think it was just kind of a perfect storm of stuff that came together,” she added.

The U.S. suffered its deadliest outbreak of bird flu in history in 2022.

“Highly pathogenic avian influenza” killed about 58 million birds across 47 states, according to the U.S. Department of Agriculture. The prior record was set in 2015, when 50.5 million birds died.  

The disease, which is contagious and lethal, affects many types of birds, including egg-laying hens.

In December, the average number of “layers” was down 5% from a year earlier, at a total 374 million birds, according to USDA data published Friday. Overall production of table eggs fell by 6.6% over the same period, to 652.2 million, data showed.

These industry figures don’t seem to square with a two- or three-digit percentage spike in egg prices last year, Farm Action claims.

“Contrary to industry narratives, the increase in the price of eggs has not been an ‘Act of God’ — it has been simple profiteering,” the group said.

For example, the profits of Cal-Maine Foods — the nation’s largest egg producer and an industry bellwether — “increased in lockstep with rising egg prices through every quarter of the year,” Farm Action claimed. The company reported a tenfold increase in profits over the 26-week period ended Nov. 26, for example, Farm Action said.

While other major producers don’t report such information publicly, “Cal-Maine’s willingness to increase its prices — and profit margins — to such unprecedented levels suggests foul play,” Farm Action wrote.

Max Bowman, Cal-Maine’s vice president and chief financial officer, denied the allegations, calling the U.S. egg market “intensely competitive and highly volatile even under normal circumstances.”

Bird flu’s significant impact on hen supply has been the most notable driver, while egg demand has remained strong, Bowman said in a written statement.

Expenses for feed, labor, fuel and packaging have also “risen considerably,” feeding through to higher overall production costs and, ultimately, wholesale and retail egg prices, he said. Cal-Maine also doesn’t sell eggs directly to consumers or set retail prices, Bowman added.

Cal-Maine’s statement seems to square with the general outlook of food economists reached by CNBC.

“We’ve never seen [these prices],” said Angel Rubio, senior analyst at Urner Barry, a market research firm specializing in the wholesale food industry. “But we also haven’t seen [avian flu] outbreaks month after month after month like this.”

In economics, markets are almost never perfectly “elastic,” Rubio said. In this case, that means there’s generally not a 1:1 relationship between egg or hen supply and egg prices.

During the prior bird-flu outbreak in 2015, wholesale egg prices rose about 6% to 8% for every 1% decrease in the number of egg-laying hens, on average, Urner Barry found in a recent analysis.

About 42.5 million layers (about 13%) have died since the 2022 outbreak, according to Urner Barry. Prices have increased about 15% for every 1% decrease in egg layers over that time, on average, Rubio said.

The dynamic is largely due to a “compounding effect” of demand, Rubio said.

For example, let’s say a big supermarket chain has a contract to buy eggs from a producer at a wholesale price of $1 per dozen. But that egg supplier then suffers a bird-flu outbreak. All supply from that source comes offline temporarily. So, the supermarket chain must then procure eggs from another supplier — raising demand for the other supplier’s eggs, which might ultimately sell eggs to the supermarket for $1.05 or more a dozen.

Once a farm suffers a flu outbreak, it likely won’t produce eggs again for at least six months, Rubio said.

This dynamic is happening simultaneously across multiple farms and supermarkets. Bird flu also generally dissipates in the summer, but outbreaks began anew in last autumn heading into peak demand season around the winter holidays, Rubio said.

Some good news for consumers may be ahead, though, economists said.

Wholesale egg prices had declined to about $3.40 a dozen as of Friday, down from a peak $5.46 a dozen on Dec. 23, Rubio said. (Current wholesale prices are still almost triple their “normal” level, Rubio said.)

On average, it takes about four weeks for wholesale price movements to be reflected in the retail market for consumers, Rubio said.

“The pricing market is already coming down post-holiday,” said Smith at Advanced Economic Solutions.

The Easter holiday is usually another period of high seasonal demand, however, meaning prices may stay elevated through March, assuming the bird-flu outbreak doesn’t worsen, economists said.

https://www.cnbc.com/2023/01/23/high-egg-prices-due-to-a-collusive-scheme-by-suppliers-group-claims.html

3 people injured in Des Moines shooting, police say

 Three people were injured Monday in a shooting in Des Moines, Iowa, according to tweets from the Des Moines Police Department.

Police say two of those injured are in critical condition. They did not provide a condition for the third person injured.

“Officers have multiple potential suspects in custody,” police said.

Des Moines police on the scene of a shooting.

The shooting was reported shortly before 1 p.m. at Starts Right Here, a charter school which helps young people living in disadvantaged circumstances, CNN affiliate KCCI reported.

Two students and one teacher were injured, KCCI said.

https://www.cnn.com/2023/01/23/us/des-moines-shooting/index.html

Head Injuries Decrease Long-Term Survival Time

 Head injuries decreased long-term survival time in a dose-dependent manner, longitudinal data showed.

All-cause mortality was twice as high for adults who had sustained a head injury earlier in life (HR 1.99, 95% CI 1.88-2.11) compared with those who had no head injury, reported Holly Elser, MD, PhD, of the University of Pennsylvania in Philadelphia, and co-authors.

Both the frequency of head hits and the severity of impact upped mortality risk, Elser and colleagues wrote in JAMA Neurology.

For adults with one head injury, mortality HR was 1.66 (95% CI 1.56-1.77); for those with two or more head injuries, HR was 2.11 (95% CI 1.89-2.37). Adults with a mild head injury had a mortality HR of 2.16 (95% CI 2.01-2.31), while those with a moderate, severe, or penetrating head injury had an HR of 2.87 (95% CI 2.55-3.22).

"Past research tells us that the risk of death is increased immediately following head injury in the hospital setting, but there is limited research that examines the long-term mortality implications of head injury, particularly among community-dwelling adults," Elser told MedPage Today.

"This study examines the association between head injury and death from all causes in more than 13,000 community-dwelling adults followed from 1987 through 2019," she continued. "Overall, these results underscore the importance of public health interventions to prevent head injuries and clinical interventions to mitigate their effects when they happen."

Traumatic brain injury (TBI) has two distinct phases, Elser and colleagues observed. Primary injury includes tissue distortion and destruction directly from the forces of the initial injury. Secondary injury occurs over time and may include blood-brain barrier dysfunction, edema, ischemia, or intracranial hypertension.

The researchers studied 13,037 participants in the prospective Atherosclerosis Risk in Communities Study (ARIC

opens in a new tab or window) study, an ongoing study in four U.S. communities. The median baseline age was 54, and the median time from enrollment to first head injury was 17 years. Overall, 72.1% of participants were white, 27.9% were Black, and 57.7% were women.

Head injury with or without loss of consciousness was based on self-report and data from emergency department visits and inpatient hospitalizations. Mortality information came from state vital records, death certificates, and the National Death Index.

A total of 2,402 participants (18.4%) had at least one head injury and 512 had two or more head injuries over a median 27 years of follow-up. Most participants (1,862 people) had head injuries identified from hospital diagnoses alone; 299 had injuries identified by self-report alone, and 241 had injuries from both hospital diagnoses and self-report.

During the study period, 7,353 participants (56.4%) died, of whom 1,552 (64.6%) were people with head injury. Median time from head injury to death was 4.7 years.

Subgroup analyses showed no evidence of a statistical interaction by sex or race, but results were attenuated for people age 54 or older at baseline. The most common causes of death were neoplasm, cardiovascular disease, and neurologic disorders.

"A greater proportion of deaths among those with head injury versus those without head injury were due to neurologic causes -- 62.2% vs 51.4%," Elser said. "Further, a greater proportion of deaths among those with head injury versus those without were due to neurodegenerative disorders -- 14.2% vs 6.6%."

The study findings could reflect that individuals who experienced head injury have increased mortality risk at baseline, that head injury causes an increase in mortality risk, or a combination of the two, Elser and co-authors acknowledged. Results might not apply to other racial or age groups, the team noted. In addition, the researchers could not distinguish between associations of primary versus secondary phases of head injury with mortality risk.

Disclosures

The ARIC study is supported by the National Heart, Lung, and Blood Institute (NHLBI). The ARIC Neurocognitive Study is supported by NHLBI, National Institute of Neurological Disorders and Stroke, National Institute on Aging, and the National Institute on Deafness and Other Communication Disorders.

Elser had no disclosures. Co-authors reported relationships with the American Academy of Neurology, the Department of Defense, and the NIH.

Primary Source

JAMA Neurology

Source Reference: opens in a new tab or windowElser H, et al "Head injury and long-term mortality risk in community-dwelling adults" JAMA Neurol 2023; DOI: 10.1001/jamaneurol.2022.5024.


https://www.medpagetoday.com/neurology/headtrauma/102757

Will Cidara Rezafungin Data for Serious Candida Infections Sway FDA Panel?

 Ahead of an advisory committee meeting on Tuesday

opens in a new tab or window, FDA staff raised concerns over whether the potential benefits of weekly rezafungin injections for adults with candidemia and invasive candidiasis (IC) outweigh any potential risks, including neurotoxicity.

According to an agency briefing documentopens in a new tab or window for the Antimicrobial Drugs Advisory Committee, potential approval of the investigational, long-acting echinocandin for candidemia and IC caused by susceptible Candida species hinges on a single phase III non-inferiority study (ReSTORE), along with data from the dose-finding phase II STRIVE study.

"The key issues for consideration in the benefit-risk assessment of rezafungin include the presumed ability to meet an unmet need in the context of generally similar (to current treatment options) effects on survival, the ability to mitigate any identified risks such as neurotoxicity, and the acceptable tradeoffs between the benefits and risks to patients," FDA staff wrote.

Candidemia and IC affect about 25,000 people per year in the U.S., according to the CDCopens in a new tab or window. The in-hospital all-cause mortality rate among people with candidemia is approximately 25%.

"There are three FDA-approved echinocandins, all of which are available only as intravenous (IV) formulations dosed once daily," FDA staff noted. "Antifungal therapy is usually continued for 2 weeks after documented clearance of Candida spp. from the blood in the case of candidemia or following adequate source control and clinical response in IC."

In the ReSTORE trial, which involved 187 subjects, rezafungin was found to be noninferior to caspofungin in the primary endpoint of all-cause mortality at 30 days in the modified intention-to-treat population, with rates of 23.7% in the rezafungin group versus 21.3% in the caspofungin group. Rezafungin was given as a 400-mg IV loading dose followed by weekly 200-mg IV doses for up to 4 weeks -- the proposed clinical dose.

The safety dataset for rezafungin, submitted by sponsor Cidara Therapeutics, included 151 patients from ReSTORE who were given the proposed clinical dose and 81 patients from STRIVE given a higher dose (400 mg administered weekly).

In this dataset, tremor was observed in 2.6% of those receiving the proposed rezafungin dose compared with zero patients receiving caspofungin. Tremor was also reported in early nonhuman primate studies.

While the ReSTORE/STRIVE data "show a similar safety profile to the FDA-approved echinocandins, the size of the dataset limits the ability to identify rare adverse reactions that may be unique to rezafungin," according to agency staff.

Although tremor has been reported to be an uncommon adverse reaction in the labeling of other echinocandins for candidemia/IC, the FDA noted that the trial data need further scrutiny.

"The review team's assessment is that the Applicant has not provided sufficient data to support the position that rezafungin provides improved activity against Candida spp. with reduced susceptibility to FDA-approved echinocandins or provides improved tissue penetration," the FDA wrote in its briefing document. "Overall, the review team finds that rezafungin is primarily distinguished from FDA-approved echinocandins by its extended half-life but welcomes the committee's input on whether rezafungin may have additional benefits that would extend treatment options for patients with candidemia/IC to address an unmet need."

All of the currently approved echinocandins, including caspofungin, anidulafungin, and micafungin, come with warnings for hypersensitivity reactions and hepatic adverse reactions in their labeling. Micafungin also has a warning for hematologic effects, renal effects, and infusion and injection site reactions, and anidulafungin has warnings related to risks associated with two of the inactive ingredients in its formulation.

"None of the echinocandins have warning statements related to neurotoxicity, and the only nervous system adverse reaction reported in >5% of patients in clinical trials was headache," the FDA wrote.

Tremor was reported as an adverse reaction occurring in less than 5% of 68 pediatric patients in an open-label non-comparative study of anidulafungin, and in the pooled safety experience from 34 studies of caspofungin in adult and pediatric patients or volunteers (n=1,951).

During the planning of the ReSTORE trial, the FDA recommended safety measures to mitigate the risk of neurotoxicity, including the exclusion of patients "with a history of neuropathy, history of tremors, or [those] receiving neurotoxic medication; addition of safety assessments for neuropathy, ataxia, and tremor; and review of safety information by the data safety monitoring board."

Currently, four classes of antifungals (echinocandins, azoles, amphotericin B formulations of polyenes, and flucytosine) have shown clinical effectiveness for the treatment of candidemia/IC. The Infectious Diseases Society of America recommends echinocandins as first-line therapy, except when infections affect the central nervous system, the eyes, or the urinary tract. The other antifungals are considered alternatives in the case of drug intolerance, drug-resistant pathogens, or as adjunctive therapy for refractory cases.

https://www.medpagetoday.com/infectiousdisease/generalinfectiousdisease/102756

Top FBI 'Russiagate' Official Took Secret Payments From Russian Oligarch: DOJ

 A former top FBI counterintelligence official - in fact, the guy who received the tip that supposedly kicked off the Trump-Russia investigation - has been arrested and charged with violating US sanctions on Russia by taking secret payments from a Russian oligarch in order to investigate another oligarch.

Charles McGonigal, the former head of counterintelligence for the FBI’s New York office.Greatdecisions.tv

Federal prosecutors in Manhattan charged Charles McGonigal, former special agent in charge of the FBI's New York counterintelligence desk, with taking secret payments from Oleg V. Deripaska - which violated US sanctions by agreeing to help the Russian billionaire, who himself was indicted last year on sanctions charges. McGonical notably retired in 2018.

During his days in counterintelligence, McGonical was responsible for supervising and participating in investigations of Russian oligarchs, including Deripaska.

The indictment unsealed in Federal District Court in Manhattan on Monday charges the former F.B.I. official, Mr. McGonigal, with one count of violating U.S. sanctions, one count of money laundering and two conspiracy counts. -NY Times

According to his lawyer, "Charlie served the United States capably, effectively, for decades," adding "We have closely reviewed the accusations made by the government and we look forward to receiving discovery so we can get a view on what the evidence is upon which the government intends to rely."

Former colleagues who worked closely with McGonigal were reportedly 'shocked' at his arrest.

They said he primarily investigated Russian counterintelligence and espionage during his lengthy career with the F.B.I. Mr. McGonigal also took on extremely sensitive assignments in the intelligence community, leading an F.B.I. team that investigated why C.I.A. informants in China were being arrested and killed. -NYT

A second man, Sergey Shestakov, was also indicted in the case. He's a former Soviet and Russian diplomat who later obtained US citizenship and worked as a Russian interpreter for courts and government offices.

https://www.zerohedge.com/political/top-fbi-russiagate-official-took-secret-payments-russian-oligarch-doj

Insulet alerts 29,000 Omnipod Dash insulin pump users to data breach linked to recall

 Insulet has issued an alert for a data breach that may have compromised the health data of thousands of users of its Omnipod Dash insulin pumps.

The devicemaker notified affected users and filed a report of the breach with the U.S. Department of Health and Human Services on Jan. 5. According to the HHS’ database, the cybersecurity incident spans around 29,000 Omnipod Dash users.

The Omnipod Dash device is a simplified version of Insulet’s flagship Omnipod 5 pump. Both offer a tubeless, waterproof makeup and three days’ worth of around-the-clock insulin delivery, but the Dash model doesn’t share its sibling’s ability to sync with a user’s continuous glucose monitor or wirelessly connect to their smartphone. Insulet didn’t immediately respond to a request for comment on the breach.

In its letter to the affected customers—a copy (PDF) of which was published online by the Montana Department of Justice—Insulet said the breach was linked to the ongoing recall of the remote controllers used with the Dash devices.

The recall began in October—and was given the FDA’s most serious Class I rating a month later—after the company discovered that the batteries in the smartphone-esque Personal Diabetes Managers (PDMs) were at risk of swelling, leaking or overheating over long periods of use. Insulet said at the time that it would voluntarily replace all PDMs currently in use, an effort that was expected to cost the company between $35 million and $45 million to complete.

According to the letter about the data breach, Insulet sent Dash users an email on or around Dec. 1 requesting acknowledgment that they’d received the medical device correction notice detailing the recall. Thanks to an improper configuration of the company’s online “cookies” and other trackers, clicking the individualized link in the email inadvertently shared certain protected health information with some of Insulet’s website performance and marketing partners, the company said.

Though no financial information, social security numbers, email addresses or passwords were exposed in the breach, the Insulet partners were able to see users’ IP addresses and whether they use a Dash pump and/or a PDM controller.

Insulet told the affected users that it has completed “an extensive review and investigation” of the breach, which the company is taking “very seriously.”

Immediately upon discovering the breach on Dec. 6—several days after the acknowledgment requests were sent out—Insulet disabled all of the clickable tracking codes to prevent further data exposure, the company said in the letter. Additionally and “where possible,” Insulet said, “we are also requesting that our partners delete logs of the IP addresses and unique URLs so that they would not continue to have access to that information.”

https://www.fiercebiotech.com/medtech/insulet-alerts-29000-omnipod-dash-users-data-breach-linked-recall-notice

With TheracosBio green light, another SGLT2 inhibitor wades into diabetes arena

 A little over a month after bexagliflozin’s approval to treat cats with diabetes, the drug has been cleared in humans.

Now christened Brenzavvy, bexagliflozin won a nod from the FDA to help improve glycemic control in adults with Type 2 diabetes, TheracosBio said Monday. The drug, which comes in 20-mg tablets, is taken once a day alongside diet and exercise.

The drug shouldn’t be used in Type 2 diabetes patients with end-stage renal disease on dialysis, TheracosBio stressed.

Back in December, bexagliflozin passed muster as the first oral therapy for cats with diabetes mellitus, with the FDA issuing a green light to Elanco Animal Health. Though the med carries “notable safety concerns” in cats, bexagliflozin holds the distinction of being the first sodium-glucose cotransporter 2 (SGLT2) inhibitor approved by the FDA for any animal species, the agency said late last year.

SGLT2 inhibitors help lower blood sugar by preventing the kidneys from reabsorbing sugar created by the body, which then leaves through the urine. The class has become a fixture in the treatment of Type 2 diabetes, where TheracosBio’s Brenzavvy will be forced to tussle with SGLT2 rivals like AstraZeneca’s Farxiga and Eli Lilly and Boehringer Ingelheim’s Jardiance.

The FDA based its approval on results from a whopping 23 trials investigating Brenzavvy in more than 5,000 Type 2 diabetes patients, TheracosBio said in a release. In phase 3 studies, Brenzavvy helped reduce patients’ hemoglobin A1c and fasting blood sugar after 24 weeks. Those benefits were seen whether Brenzavvy was given as a monotherapy, in combination with metformin or as an add-on to standard-of-care treatment comprising a range of regimens.

As with other SGLT2 meds, Brenzavvy—while not specifically approved for weight loss or blood pressure reduction—has the potential to help patients chart “modest decreases in both weight and systolic blood pressure,” TheracosBio said.

Elsewhere, the green light has likely caught the attention of Wanbang Biopharmaceuticals and Canadian biotech Sirona Biochem, which recently expanded a pact around Sirona’s SGLT2 inhibitor TFC-039.

Alongside its use in humans, Sirona is also exploring TFC-039’s potential as a diabetes and chronic kidney disease treatment in companion animals, thanks to SGLT2 inhibitors’ convenient oral dosing.

https://www.fiercepharma.com/pharma/theracosbio-green-light-another-sglt2-inhibitor-wades-type-2-diabetes-arena