HealthDay News — “Pharma bro” Martin Shkreli may have violated a judge’s order banning him from being involved in the pharmaceutical industry, the US Federal Trade Commission announced Friday.

Shkreli, who was convicted for an illegal scheme to maintain a monopoly on the lifesaving toxoplasmosis drug Daraprim, could now be held in contempt of court for forming a new company called Druglike.

Since last February, Shkreli has been banned “for life from directly or indirectly participating in any manner in the pharmaceutical industry” because of the FTC antitrust lawsuit against him and a ruling by Manhattan federal court Judge Denise Cote. Shkreli has also failed to pay $25 million, his share of a $64.6 million judgment, in the FTC lawsuit, the FTC said.

In the court filing, the FTC and a group of states that had sued Shkreli said he has not complied with requests for documents or an interview about whether his involvement with Druglike violates the ban. Shkreli announced the formation of the new company in July, the FTC said, and it appears Druglike is “involved in the drug industry.”

“Martin Shkreli’s failure to comply with the court’s order demonstrates a clear disregard for the law,” Holly Vedova, director of the FTC Bureau of Competition, said in a statement. “The FTC will not hesitate to deploy the full scope of its authorities to enable a comprehensive investigation into any potential misconduct.”

More Information

Shria Kumar, MD, from the University of Miami, and colleagues evaluated the results of community-based HP testing in an at-risk, underserved population. The analysis included 155 participants undergoing testing using a portable urea breath test machine.

The researchers found that 34% of participants had HP infection, 63% were negative, and 3% were indeterminate. HP infection was significantly more common among participants who were Hispanic/Latino (79 vs 54%), younger (48 vs 52 years), and non-English speakers (Spanish-speaking: 67 vs 30%). Among the 52 participants with infection, 42% were retested with confirmed eradication, 37% were unable to be recontacted, and 19% did not complete treatment. Barriers identified by participants included medication tolerability, frequent dosing, and logistics of attending a second testing session. High motivation for testing and treatment was seen among those with familiarity of the association between HP and gastric cancer.

“While our medication-focused eradication rate is 96%, suggesting acceptable rates of eradication based on antibiotic efficacy, an intention-to-treat analysis yields markedly lower results: among 52 with infection, only 42% had confirmed eradication,” the authors write.

Abstract/Full Text (subscription or payment may be required)

Jane R. Montealegre, PhD, from the University of Texas MD Anderson Cancer Center in Houston, and colleagues evaluated the effectiveness of mailed at-home self-sampling for HPV testing in a safety-net health system setting. The analysis included data from 2115 patients who were randomly assigned to one of the 3 following arms: telephone recall to provider-performed screening (usual care; arm 1); telephone recall + mailed self-sampling kit for HPV testing (arm 2); or telephone recall + mailed self-sampling kit + telephone-based patient navigation (arm 3).

The researchers found that among participants, the median time since last screening test was 9.5 years. Screening participation across arms 1, 2, and 3 was 15.3, 44.0, and 51.4%, respectively. Compared with usual care (arm 1), the relative incidence of screening in arms 2 and 3 was 2.90 and 3.36, respectively. For arm 3 vs arm 2, the relative incidence of screening was 1.16.

“After US Food and Drug Administration approval, self-sampling for high-risk-HPV testing has the potential to dramatically increase participation in cervical cancer screening in underserved populations,” the authors write.

Abstract

More Information

HealthDay News — During the pandemic, nearly 100,000 US registered nurses called it quits, a new survey shows. A combination of stress, burnout, and retirements created a perfect storm for the exodus.

Even worse, another 610,000 registered nurses (RNs) said they had an “intent to leave” the workforce by 2027, citing those same reasons. And an additional 189,000 RNs younger than 40 years reported similar intentions, the study from the National Council of State Boards of Nursing (NCSBN) revealed. Put together, this means about one-fifth of the 4.5 million registered nurses nationally could leave the health care workforce in a short time period.

“The data is clear: the future of nursing and of the US health care ecosystem is at an urgent crossroads,” Maryann Alexander, chief officer of nursing regulation at the NCSBN, said in a council news release. “The pandemic has stressed nurses to leave the workforce and has expedited an intent to leave in the near future, which will become a greater crisis and threaten patient populations if solutions are not enacted immediately.”

The survey laid bare the pandemic’s impact on nursing, and examined the personal and professional characteristics of nurses experiencing heightened workplace burnout and stress due to the pandemic.

Data were gathered as part of a biennial nursing workforce study conducted by NCSBN and the National Forum of State Nursing Workforce Centers. Among the findings: 62% of nurses sampled said they had an increase in workload during the pandemic; nearly 51% said they felt emotionally drained; and 56% said they felt used up. About 50% of nurses reported being fatigued; 45% said they were burned out; and 29% were at the end of their rope “a few times a week” or “every day.”

These concerns were most pronounced in nurses with 10 or fewer years of experience, according to the report. This drove an overall 3.3% decline in the US nursing workforce in the past two years. Meanwhile, the number of licensed practical/vocational nurses, who generally work in long-term care settings, declined by nearly 34,000 since the beginning of the pandemic.

Pandemic disruptions in nursing programs have also raised concerns about the supply and clinical preparedness of new nurse graduates. Early career data for these new nurses suggest decreased practice and assessment proficiency, according to the researchers.

More Information

HealthDay News — Partial or complete COVID-19 vaccination is associated with a lower risk for major adverse cardiac events (MACE) after SARS-CoV-2 infection, according to a research letter published in the March 7 issue of the Journal of the American College of Cardiology to coincide with the annual meeting of the American College of Cardiology, held from March 4 to 6 in New Orleans.

Joy Jiang, of the Icahn School of Medicine at Mount Sinai in New York City, and colleagues examined the association between vaccination and MACE among patients with prior SARS-CoV-2 infection. The analysis included 1.93 million patients identified from the National COVID Cohort Collaborative.

The researchers found that of the 13,948 patients experiencing MACE, most events occurred in the 12,733 nonvaccinated patients, while 160 events occurred in partially vaccinated patients and 1055 occurred in fully vaccinated patients. The median time to MACE from index infection was 17 days. Comorbidities significantly differed in patients with and without MACE, including previous MACE (29.1 vs 0.9%), type 2 diabetes (33.9 vs 7.5%), hyperlipidemia (50.7 vs 14.4%), ischemic heart disease (40.6 vs 3.9%), liver disease (4.0 vs 0.8%), and obesity (29.4 vs 16.4%). Full (adjusted hazard ratio, 0.59) and partial vaccination (adjusted hazard ratio, 0.76) were associated with a reduced risk for MACE. Male sex, age (notably 66 years and older), and comorbidities (notably previous MACE) were associated with a significantly increased risk for MACE.

“To our surprise, even partial vaccination was associated with lower risk of adverse cardiovascular events,” Jiang said in a statement. “Given the magnitude of SARS-CoV-2 infection worldwide, we hope our findings could help improve vaccination rates, especially in individuals with coexisting conditions.”

Several authors disclosed financial ties to the biopharmaceutical industry.

Abstract/Full Text (subscription or payment may be required)

More Information

Originally approved in 2019, Jynneos was developed in collaboration with the US government to ensure a supply of a smallpox vaccine for the entire population. During the mpox outbreak in 2022, the US Department of Health and Human Services (HHS) expanded access to Jynneos to mitigate the spread of the infection, while the Food and Drug Administration (FDA) granted emergency use authorization for intradermal injection in individuals 18 years of age and older and subcutaneous injection in those younger than 18 years of age who were determined to be at high risk.

“Since the outbreak of mpox last year, Bavarian Nordic has supplied millions of doses of our vaccine to more than 70 countries worldwide, which has had a positive impact on controlling this unprecedented outbreak of mpox,” said Paul Chaplin, President and CEO of Bavarian Nordic. “The broadened ACIP recommendation recognizes the significance of maintaining a high awareness of the disease among risk groups and the importance of ensuring broader access to the vaccine beyond an outbreak situation.”

The recommendation has been adopted by the Director of the CDC and is now included in the 2024 adult immunization schedule. Bavarian Nordic intends to launch Jynneos in the US in the first half of 2024. 

“Entering the private mpox vaccine market in the US offers an opportunity to provide improved access to Jynneos and to build a steady commercial business segment, complimenting the existing smallpox stockpiling business with the US government,” added Chaplin.

Jynneos is administered by subcutaneous injection as 2 doses (0.5mL each) 4 weeks apart. Each vial contains a single dose (0.5mL).

Last Reviewed: December 5, 2023

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices has issued new guidelines for the prevention and control of seasonal influenza with vaccines for the 2023-2024 season. Routine annual influenza vaccination is recommended for all patients 6 months of age and older who have no contraindications. Vaccination should ideally be completed by October though it should be offered throughout the season if influenza viruses continue to circulate.

For the 2023–2024 season, all influenza vaccines are expected to be quadrivalent, containing hemagglutinin (HA) derived from one influenza A(H1N1)pdm09 virus, one influenza A(H3N2) virus, one influenza B/Victoria lineage virus, and one influenza B/Yamagata lineage virus.

Egg-based influenza vaccines:

• Will contain HA derived from an influenza A/Victoria/4897/2022 (H1N1)pdm09-like virus, an influenza A/Darwin/9/2021 (H3N2)-like virus, an influenza B/Austria/1359417/2021 (Victoria lineage)-like virus, and an influenza B/Phuket/3073/2013 (Yamagata lineage)-like virus.
• These include Afluria Quadrivalent, Fluarix Quadrivalent, FluLaval Quadrivalent, Fluzone Quadrivalent (all standard dose), Fluzone High-Dose Quadrivalent (high-dose formulation), Fluad Quadrivalent (standard dose with MF59 adjuvant), and FluMist Quadrivalent intranasal spray.

Cell culture-based inactivated or recombinant influenza vaccines:

• Will contain HA derived from an influenza A/Wisconsin/67/2022 (H1N1)pdm09-like virus, an influenza A/Darwin/6/2021 (H3N2)-like virus, an influenza B/Austria/1359417/2021 (Victoria lineage)-like virus, and an influenza B/Phuket/3073/2013 (Yamagata lineage)-like virus.
• These include Flucelvax Quadrivalent (standard dose cell culture-based) and Flublok Quadrivalent (recombinant).

Updates to the guidance for this upcoming influenza season include the following:

• ACIP recommends all persons 6 months of age and older with egg allergy receive influenza vaccine (egg-based or nonegg-based) that is otherwise appropriate for the recipient’s age and health status.
  • It is no longer recommended that individuals who have had an allergic reaction to egg with symptoms other than urticaria should be vaccinated in a medical setting supervised by a health care provider who is able to recognize and manage severe allergic reactions if an egg-based vaccine is used.
  • Egg allergy alone does not require additional safety measures for influenza vaccination beyond those recommended for any recipient of any vaccine, regardless of severity of previous reaction to egg.
  • All vaccines should be administered in settings in which personnel and equipment needed for rapid recognition and treatment of acute hypersensitivity reactions are available.
  • Additional information about this recommendation can be found here.

Regarding simultaneous administration of influenza vaccine with the new respiratory syncytial virus (RSV]) vaccine, data included in the prescribing information for GSK’s Arexvy show no evidence for interference in the immune response to any of the antigens contained in both concomitantly administered vaccines. In this study (ClinicalTrials.gov Identifier: NCT04841577), participants 60 year of age and older received 1 dose of Arexvy and Fluarix Quadrivalent. The criteria for noninferiority of the immune responses in the control vs coadministration group were met, though RSV and influenza antibody titers were somewhat lower with coadministration; the clinical significance of this is unknown.

The full report, which includes guidance for influenza vaccination of specific populations (eg, children, pregnant people, older patients, immunocompromised individuals), and situations (eg, history of Guillain-Barré Syndrome) can be found here.

In a retrospective cohort study at 619 US hospitals, Jeffrey R. Strich, MD, from the National Institutes of Health in Bethesda, Maryland, and colleagues examined use patterns of recently US Food and Drug Administration-approved gram-negative antibiotics and identified factors associated with their preferential use over traditional generic agents in patients with gram-negative infections due to pathogens displaying difficult-to-treat resistance (DTR).

The researchers found that ceftolozane–tazobactam (approved in 2014) and ceftazidime–avibactam (approved in 2015) predominated new antibiotic usage between quarter 1 of 2016 and quarter 2 of 2021, while there was relatively low uptake of subsequently approved gram-negative antibiotics. Overall, 0.7% of the gram-negative infection hospitalizations displayed DTR pathogens. In 41.5% of DTR episodes, patients were treated exclusively using traditional agents, including reserve antibiotics such as polymyxins, aminoglycosides, and tigecycline in 79.3%. The adjusted probability of receiving newer versus traditional antibiotics for DTR infections was greater for patients with bacteremia and chronic diseases and was lower for those with do-not-resuscitate status, acute liver failure, and Acinetobacter baumannii complex and other nonpseudomonal nonfermenter pathogens.

“There is a stark imbalance between available new antibiotics and unmet pathogen targets,” the authors write. “These findings call for paradigm-changing countermeasures.”

Abstract/Full Text (subscription or payment may be required)

Editorial (subscription or payment may be required)

More Information

Acute Otitis Media Treatments

HealthDay News — An adenovirus serotype 26 respiratory syncytial virus (RSV) vector encoding a prefusion F (preF) protein (Ad26.RSV.preF) in combination with RSV preF protein is immunogenic and prevents RSV-mediated lower respiratory tract disease in older adults, according to a study published in the February 16 issue of the New England Journal of Medicine.

Ann R. Falsey, MD, from the University of Rochester School of Medicine in New York, and colleagues conducted a phase 2b, proof-of-concept trial to examine the efficacy, immunogenicity, and safety of Ad26.RSV.preF-RSV preF protein vaccine among adults aged 65 years or older. A total of 5782 participants were randomly assigned to receive vaccine or placebo in a 1:1 ratio. The primary end point was the first occurrence of RSV-mediated lower respiratory tract disease that met one of three case definitions.

The researchers found that RSV-mediated lower respiratory tract disease meeting case definitions 1, 2, and 3 occurred in six, 10, and 13 and in 30, 40, and 43 vaccine and placebo recipients, respectively. For case definitions 1, 2, and 3, vaccine efficacy was 80.0, 75.0, and 69.8%, respectively. From baseline to day 15 after vaccination, RSV A2 neutralizing antibody titers increased by a factor of 12.1. Compared with the placebo group, the percentages of participants with solicited local and systemic adverse events were higher in the vaccine group (local: 37.9 vs 8.4%; systemic: 41.4 vs 16.4%); most adverse events were mild to moderate. The frequency of serious adverse events was similar between the groups.

“Vaccine efficacy, immunogenicity, and safety were maintained across subgroups defined according to age and the presence of additional risk factors for severe RSV-mediated disease,” the authors write.

The study was funded by Janssen Vaccines and Prevention, which manufactures the Ad26.RSV.preF-RSV preF vaccine.

Abstract/Full Text (subscription or payment may be required)

Trisha N. Peel, MB, BS, PhD, from Monash University in Melbourne, Australia, and colleagues conducted a multicenter, superiority, placebo-controlled trial in which adult patients without known methicillin-resistant Staphylococcus aureus (MRSA) colonization who were undergoing arthroplasty were randomly assigned to receive 1.5g vancomycin or normal saline placebo in addition to cefazolin prophylaxis. The modified intention-to-treat analysis included 4113 patients: 2233 undergoing knee arthroplasty; 1850 undergoing hip arthroplasty; and 30 undergoing shoulder arthroplasty.

The researchers found that surgical site infections occurred in 4.5 and 3.5% of patients in the vancomycin and placebo groups, respectively, among the modified intention-to-treat population (relative risk, 1.28; 95% CI, 0.94 to 1.73; P =.11). Surgical site infection occurred in 5.7 and 3.7% of patients in the vancomycin and placebo groups, respectively, among those undergoing knee arthroplasty (relative risk, 1.52; 95% CI, 1.04 to 2.23). For those undergoing hip arthroplasty, the corresponding proportions were 3.0 and 3.1% (relative risk, 0.98; 95% CI, 0.59 to 1.63). Adverse events occurred in 1.7% of patients in both the vancomycin group and the placebo group.

“In this pragmatic, randomized trial involving adult patients undergoing arthroplasty who had a low prevalence of MRSA colonization, the addition of vancomycin was not superior to surgical antimicrobial prophylaxis with cefazolin,” the authors write.

Abstract/Full Text (subscription or payment may be required)

Kalyani Sonawane, from the Medical University of South Carolina in Charleston, and colleagues compared the factors associated with parental HPV vaccination intentions between socioeconomically divergent groups. The analysis included data from 212,643 adolescents (105,958 unvaccinated or not fully vaccinated) participating in the 2017 to 2021 National Immunization Survey-Teen.

The researchers found that in the advantaged group, 64.7% of parents of unvaccinated adolescents (equating to 2.4 million US adolescents) had no intention to initiate the HPV vaccine vs 40.9% of parents in the deprived group (equating to 0.2 million adolescents). In the advantaged group, the most frequent reason for lacking intent was “safety concerns” (25.5%), whereas in the deprived group, “lack of knowledge,” “not recommended,” and “not needed” were common reasons (nearly 15% each). The advantaged group had a higher lack of intent to complete the HPV vaccine series (43.9%; 1.1 million adolescents) versus the deprived group (25.2%; 0.08 million adolescents). More than half in the advantaged group (58.4%) and more than one-third in the deprived group (37.1%) cited “already up to date” as the primary reason for not completing the HPV vaccine series.

“Interventions that provide facts on vaccine safety and effectiveness and debunk HPV vaccine myths at an individual- and/or community-level, along with strong recommendations by health care providers, will be necessary to avoid stagnation of HPV vaccine rates and to continue making progress towards achieving the 80% national goal,” the authors write.

One author disclosed ties to Merck.

Abstract/Full Text

HealthDay News — Recent COVID-19 infection seems not to be associated with the risk for adverse postoperative outcomes, according to a research letter published online March 28 in JAMA Network Open.

William J. O’Brien, from the Center for Healthcare Organization and Implementation Research at Veterans Affairs Boston, and colleagues examined the risk for adverse postoperative outcomes among patients with recent infection, emulating a trial conducted in a large veteran population. A total of 29,093 patients (mean age, 66.1 years) underwent surgery at 123 hospitals from January 1 to September 30, 2021.

The researchers noted there was a median of 30 days between infection and surgery. Overall, 4.7% of the 28,635 patients without COVID-19 had adverse postoperative outcomes compared with 7.6 and 3.2% within the group with a one- to 30-day infection and the group with a 31- to 60-day infection, respectively. Among those with infection during preoperative days 1 to 30 and 31 to 60, the odds ratios for any adverse postoperative outcomes, including 30-day mortality, cardiac outcomes, central nervous system outcomes, respiratory outcomes, infection disease outcomes, or thromboembolic outcomes, were 1.40 (95% CI, 0.77 to 2.35) and 0.68 (95% CI, 0.26 to 1.42), respectively.

“Current evidence suggests the decision to proceed should be based on clinical expertise rather than a fixed time interval after infection, consistent with current guidelines,” the authors write.

One author disclosed financial ties to the pharmaceutical industry.

Abstract/Full Text

On behalf of the AGA, Anne F. Peery, MD, from the University of North Carolina at Chapel Hill, and colleagues developed guidelines to provide recommendations on use of fecal microbiota-based therapies in adults with recurrent C. difficile infection, severe to fulminant C. difficile infection, inflammatory bowel diseases, including pouchitis, and irritable bowel syndrome. The Evidence-to-Decision framework was used to develop recommendations and provide considerations for implementation in clinical practice.

The guideline panel developed 7 recommendations. The AGA suggests select use of fecal microbiota-based therapies upon completion of standard-of-care antibiotics to prevent recurrence among immunocompetent adults with recurrent C. difficile. Use of conventional fecal microbiota transplant is suggested in mildly or moderately immunocompromised adults with recurrent C. difficile infection. The AGA suggests against use of any fecal microbiota-based therapies to prevent recurrent C. difficile in severely immunocompromised adults. Select use of conventional fecal microbiota transplant is suggested for adults hospitalized with severe or fulminant C. difficile not responding to standard-of-care antibiotics. Except in the context of clinical trials, the AGA suggests against use of conventional microbiota transplant as treatment for inflammatory bowel diseases or irritable bowel syndrome.

“Fecal microbiota transplant is a safe and effective treatment with enough scientific evidence to be offered to most patients with two or more C. diff recurrences,” Peery said in a statement.

Abstract/Full Text

HealthDay News — For patients with community-acquired pneumonia (CAP), a deep learning (DL) model using initial chest radiographs can predict 30-day mortality, according to a study published online June 14 in the American Journal of Roentgenology.

Changi Kim, from Seoul National University Hospital in South Korea, and colleagues developed a DL model to predict 30-day mortality in patients with CAP using chest radiographs from the time of diagnosis from 7105 patients from one institution. The model was evaluated in patients diagnosed with CAP during emergency department visits from the same institution (temporal test model [947 patients]) and from 2 additional different institutions (external test cohorts A and B [467 and 381 patients, respectively]).

The researchers found that in the temporal test set, the area under the receiver operating characteristic curve (AUC) for predicting 30-day mortality was higher for the DL model than the established risk prediction CURB-65 score (0.77 vs 0.67, respectively); in external test cohorts A and B, the higher AUC for the DL model was not significant compared with CURB-65 (0.80 vs 0.73 and 0.80 versus 0.72, respectively). In the 3 cohorts, the DL model exhibited significantly higher specificity (range, 61 to 69 vs 44 to 58%, respectively) at the same sensitivity achieved by the CURB-65 score. Compared with the CURB-65 score, combination of the DL model and CURB-65 score yielded an increase in AUC in the temporal test cohort and external test cohort B (0.77 and 0.80, respectively).

“The DL model may guide clinical decision-making in the management of patients with CAP by identifying high-risk patients who warrant hospitalization and intensive treatment,” the authors write.

Two authors disclosed financial ties to Lunit.

Abstract/Full Text (subscription or payment may be required)

(HealthDay News) — Alcohol use is not associated with lower odds of sustained virologic response (SVR) among patients initiating direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection, according to a study published online Sept 26 in JAMA Network Open.

Emily J. Cartwright, MD, from the Atlanta Veterans Affairs Medical Center, and colleagues evaluated whether alcohol use at DAA treatment initiation is associated with a decreased likelihood of SVR. The analysis included 69,229 patients with chronic HCV infection who initiated DAA therapy between Jan 1, 2014, and June 30, 2018.

The researchers found that 94.4% of patients achieved SVR. Overall, 46.6% of participants were abstinent without alcohol use disorder (AUD), 13.3% were abstinent with AUD, 19.4% had lower-risk consumption, 4.5% had moderate-risk consumption, and 16.2% had high-risk consumption or AUD.

There was no difference in SVR across alcohol use categories, even for patients with high-risk consumption or AUD when adjusting for other confounders (odds ratio, 0.95; 95% CI, 0.85-1.07). Furthermore, there was no interaction by stage of hepatic fibrosis measured by fibrosis-4 score.

“These findings suggest that restricting access to DAA therapy on the basis of alcohol use creates an unnecessary barrier for patients and challenges HCV elimination goals,” the authors write.

One author disclosed ties to the pharmaceutical industry.

Abstract/Full Text