Hundreds evaded airport security in 2023, TSA says

 They certainly didn’t have pre-check.

The Transportation Security Administration saw an alarming number of passengers covertly bypassing airport security last year, the Washington Post reported.

“It is a larger number than we realized,” TSA spokesperson R. Carter Langston told the outlet, adding that there have been at least 300 cases since March 2023.

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A considerable number of people made it through airport security undetected last year.Mariakray

The TSA is probing the weak security checkpoints allowing unscreened people to slip through, which have been labeled a “trend.”

One of the most popular ways that is happening — more than 200 were seen doing so — is people cutting through exit lanes typically marked with “no re-entry” signage.

Meanwhile, an additional 80 slipped past the travel document checker (TDC) podium used to review flyers’ identification and credentials. That’s compared to 72 in 2022 and 29 in 2019.

Still, those who skipped the document station did undergo body screenings.

Others have been caught red-handed trying to skip the line, Langston said, noting that “a lot of people lose their patience.”

Still, he also claimed that the “vast majority do not seem to have evil intent” in that most cases seem accidental.

New Jersey TSA Security Director Thomas Carter doubled down, adding that many are either not thinking clearly or forgot some of their belongings.

“Many times it’s left-behind property; people get very upset, it’s almost like they lose their minds. ‘I have to get my cellphone. I have to get my laptop,’” said Carter, who has seen an uptick of security lapses at Newark Liberty International Airport.

However, some attempt to sneak on a flight for which they don’t have a ticket, as was the case for a Nashville woman in February.

Carter noted that a clear post-pandemic “change in behavior” in passengers could be a factor.

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Reasons people are skipping security lines are not always malicious, experts say.baona

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Newark Airport is relying on plastic or glass partitions to stop people from skipping security checkpoints.Eloi_Omella
At Newark Airport, a prospective solution — closing off areas with glass or plastic barriers rather than standard stanchions with retractable nylon “belts” — has been implemented to narrow security risks.

Carter said the new barriers have “been very effective in helping us prevent any access control events or attempted breach past the TDC.”

https://nypost.com/2024/04/05/lifestyle/hundreds-evaded-airport-security-in-2023-tsa-says/

Vaping May Help People Quit Smoking Cigarettes After All

 Combustible cigarette smokers are now more likely to quit if they start on e-cigarettes, a trend not seen a decade ago, according to longitudinal data from adults in the Population Assessment of Tobacco and Health (PATH) study.

Between 2016-2017 and 2018-2019, 20.1% of adult smokers who used electronic nicotine delivery systems discontinued cigarette smoking at follow-up compared with 16.5% of those who did not use e-cigarettes (P<0.05), reported Karin Kasza, PhD, of Roswell Park Comprehensive Cancer Center in Buffalo, New York, and co-authors.

This trend continued between 2018-2019 to 2021, with 30.9% of those who used e-cigarettes discontinuing cigarette smoking at follow-up compared with 20% of those who did not use e-cigarettes (P<0.001), they detailed in Nicotine & Tobacco Researchopens in a new tab or window.

Of note, between 2013 and 2016, rates of discontinuing cigarette smoking among U.S. adults were almost identical between those who used e-cigarettes, at 15.5%, and those who did not, at 15.6%.

"Our findings here suggest that the times have changed when it comes to vaping and smoking cessation for adults in the U.S.," said Kasza in a press releaseopens in a new tab or window. "While our study doesn't give the answers as to why vaping is associated with cigarette quitting in the population today when it wasn't associated with quitting years ago, design changes leading to e-cigarettes that deliver nicotine more effectively should be investigated. This work underscores the importance of using the most recent data to inform public health decisions."

The researchers explained that in the nearly 20 years since electronic nicotine delivery system products entered the market, there have been varied results regarding the role they play in quitting smoking. These findings follow a recent randomized trialopens in a new tab or window that showed e-cigarettes helped people better stick to smoking cessation.

"Our full study period spanned a time in the United States when the ENDS [electronic nicotine delivery systems] marketplace was expanding; salt-based nicotine formulations gained market share in 2016 and ENDS products became available with increased nicotine yields over time, prevalence of ENDS use and frequent ENDS use was increasing, and various tobacco control actions were taken at state and federal levels," the group wrote.

"Inconsistent findings may be due in part to differences in the samples and measures considered, differences in analytic approaches used, and/or may be because of the rapidly changing product environment or differing policy contexts," they added.

Joan Burnham, MSN, RN, an oncology nurse navigator at Houston Methodist Sugar Land Hospital in Texas, told MedPage Today via email that one factor that may contribute to e-cigarettes working as a smoking cessation tool is the nicotine concentration of those devices, which may be higher than those of regular cigarettes.

"The difficulty in quitting smoking is related to the nicotine addiction that people have to go through when quitting," she said. "If you are getting a higher level of nicotine from the ENDS, the withdrawal and nicotine craving is completely alleviated."

Farrah Kheradmand, MD, of Baylor College of Medicine in Houston, stressed that replacing one type of nicotine with another can still be dangerous.

She told MedPage Today that some research indicates high relapse rates among those who switch from smoking to a form of nicotine replacement, and that the urge to smoke will likely remain, as "using nicotine in an electronic cigarette is a sure sign of nicotine dependency."

"Therefore, all in all, I would not see these data as encouraging or suggestive that electronic cigarettes enable adults to quit smoking. They are replacing nicotine usage from one type to another, which will not result in true smoking cessation," she said.

For this study, Kasza and team used data on adults ages 21 and up from waves 1-6 (2013-2021) of the PATH study. Median age was 41, 54% were men, 64.6% were white, 15.1% were Black, and 13.5% were Hispanic. Some level of college or an associate's degree was the most common education level, at 33.4%, followed by high school graduates at 27.3%, less than a high school/general equivalency diploma at 25.5%, and a Bachelor's degree or more at 13.4%.

Participants completed audio computer-assisted self-interviews that were provided to them in either English or Spanish. Since wave 6 overlapped with the onset of the COVID-19 pandemic, interview data were obtained via both audio computer-assisted self-interviews and telephone interviews.

The researchers noted that limitations to the study included the fact that data on e-cigarette use were not tracked between baseline and follow-up waves and subgroup analyses for different patient populations were not conducted. Furthermore, the reasons why people stopped smoking regular cigarettes were not identified.

Disclosures

This study was funded by the National Institute on Drug Abuse, the National Institutes of Health, the Center for Tobacco Products, the FDA, and HHS.

Kasza reported no disclosures. A co-author reported long-term stock holdings in the General Electric Company, 3M Company, and Pfizer.

Burnham and Kheradmand reported no disclosures.

Primary Source

Nicotine & Tobacco Research

Source Reference: opens in a new tab or windowKasza KA, et al "Divergence in cigarette discontinuation rates by use of electronic nicotine delivery systems (ENDS): longitudinal findings from the United States PATH study waves 1-6" Nic & Tob Res 2024; DOI: 10.1093/ntr/ntae027.

https://www.medpagetoday.com/pulmonology/smoking/109496

Wrangle Over Whether Combo Vaccines Are Beneficial for Adults

 The benefits of combination vaccines may seem obvious (fewer visits, less discomfort), but their development for adults is not without challenges, pharmaceutical company experts said at the World Vaccine Congress

opens in a new tab or window on Wednesday.

Combination vaccines have been available for children for decades, but whether they're also needed for adults, and for which viruses, have been debated.

"I think combination vaccines have the potential for enormous public health benefit," said Kayvon Modjarrad, MD, PhD, executive director of vaccine research and development for Pfizer.

In addition to the convenience of fewer shots and fewer sore arms, combination vaccines have the potential to reduce the burden of vaccination on the overall healthcare system and improve equity, he noted.

Francesca Ceddia, MD, chief medical affairs officer for Moderna, said another perk of combined vaccines is the potential to increase coverage rates.

Despite rates of hospitalizations and deaths from COVID-19 being two to five times higher than those for influenza, people don't question flu vaccines the way they do COVID vaccines, Ceddia said, adding that she anticipates that a combination COVID/flu vaccine could help normalize COVID vaccination.

"People do not question why [they] should get diphtheria, tetanus, pertussis, etc.," she pointed out.

Ceddia also highlighted the potential to increase vaccine uptake for lesser known illnesses -- for example, by pairing vaccination for respiratory syncytial virus (RSV) with human metapneumovirus (HMPV).

The primary criteria for pairing two diseases in one vaccine is to have overlapping epidemiology and indications, the panelists said.

In the case of RSV and HMPV, both are respiratory pathogens that affect the upper and lower respiratory tracts, and both impact a similar population -- young children and older adults, Ceddia told MedPage Today in a follow-up email, adding that HMPV is "very similar" to the antigen for RSV.

The viruses also have matching seasonality and a similarly underestimated burden of disease, even more so for HMPV, she said. Moderna is working on such a vaccine and to date has completed phase I trials in pediatric populations.

Looking at less ideal combinations, duration of protection matters. It's unclear how long the current RSV vaccine will protect people, but if that duration is longer than for COVID or flu, pairing RSV with either gets increasingly more complicated. "This is what we're learning," Ceddia said, based on data that are currently being collected.

Piyali Mukherjee, MPH, vice president and head of global medical affairs, vaccines, for GSK, also noted that she sees clear benefits from combination vaccines in adults, and "with so many new technologies -- mRNA, mAbs [monoclonal antibodies] -- I'm sure this space will only grow."

Robert Walker, MD, chief medical officer for Novavax, was more skeptical.

In considering the "value proposition" of combination vaccines for adults, one should look at the injection burden and current vaccine schedule, he said. Children receive approximately 27 separate injections in their first 2 years, with as many as six in one visit.

"Clearly, there's an injection burden there, and there's a medical need," he said. "Do we have the same problem in the adult sector?"

Walker also challenged the idea that a combination flu/COVID vaccine might improve COVID vaccination uptake.

"Equally possible is that the COVID [vaccine] could be pulling the flu acceptance down," he said.

However, a 2023 meta-analysisopens in a new tab or window suggested the opposite: that combining flu vaccines and COVID boosters "can be an effective strategy for increasing the uptake of the latter by populations that have shown reluctance against taking it," the authors wrote.

Ceddia is confident that the negativity and misconceptions around COVID vaccines will dissipate, she told MedPage Today, especially as awareness that vaccination prevents not only acute symptoms but also long COVID increases.

Furthermore, reducing the number of visits for vaccine administration "saves cost and time," she added. "If we assume [combination vaccines] could potentially increase compliance and adherence to vaccination, and improve coverage rates, there would be savings in terms of healthcare cost utilization."

Panelists were also asked about other specific challenges in development, including the potential for immune interference -- the belief that the immune system can become overloaded with simultaneous exposures to more than one vaccine -- and the "upper limit of toxicity" (the point at which increasing the dose of a vaccine changes the adverse event profile).

Modjarrad stressed that these are important considerations. There are already inherent complexities to developing a combination COVID/flu vaccine. For instance, there are multiple antigens present in the flu vaccine itself, which is why Pfizer is taking a "very deliberate, phased approach to this," and starting with two vaccines, not four or five, he said.

Mukherjee added that some immune interference is to be expected. That's why it's important to know what level of interference actually matters, then do studies and collect the data, she said.

As for vaccine reactogenicity, "this is where platform optimization will become very, very important," she noted. In early studies of GSK's partnership with CureVacopens in a new tab or window, for example, "even at the highest dose ranges [that were tested], you do have a much lower level of reactogenicity."

Walker said that Novavax has seen interference between flu and COVID in phase II studies using recombinant protein nanoparticle platform technology, and therefore increased the amount of antigen, but the platform "can accommodate a lot of antigen."

"As we drive up antigen, our experience has been that the reactogenicity is indistinguishable from the lowest antigen dose levels," he said.

Also, as Ceddia pointed out, regulators are quick to remind companies that if a vaccine doesn't perform in the same way as the original, it's unlikely to move forward.

"It's a very complex field," she said, but knowing what has worked in the pediatric space, "there is reason to believe that it could also work in the adult space."

https://www.medpagetoday.com/infectiousdisease/vaccines/109502

Genetic Test for Opioid Addiction Risk Should Be Withdrawn, Researcher Group Tells FDA

 A group of 31 physicians and researchers called on the FDA to reverse its decision about AvertD, a test that uses DNA to identify whether adults may have an elevated risk of developing opioid use disorder (OUD).

In a letter to FDA Commissioneropens in a new tab or window Robert Califf, MD, experts in genetics, addiction, psychiatry, public health, and device regulation asked the agency to revoke its recent approval of AvertD, based on research that doesn't support the methodology used by the test's sponsor.

The group also sent a letter to Centers for Medicare & Medicaid Servicesopens in a new tab or window (CMS) Administrator Chiquita Brooks-LaSure asking CMS to deny coverage of AvertD.

The FDA approvedopens in a new tab or window AvertD in December 2023. The prescription-only genetic test from SOLVD Health is expected to be on the market soon.

AvertD detects the presence of 15 single nucleotide polymorphismsopens in a new tab or window (SNPs) to help identify people who may have an increased risk of OUD. It's intended to be used in combination with clinical evaluations and patient assessments when oral prescription opioids are being considered to treat acute pain.

The major risks associated with AvertD are false-negative and false-positive results, the FDA said. Before the agency approved it, an FDA advisory committee voted strongly against an earlier version of AvertD, with false-negative and false-positive test resultsopens in a new tab or window being a primary concern.

"The FDA seems to believe the test isn't a very good test but that it's better than nothing. They've got it wrong," said Andrew Kolodny, MD, an opioid policy expert at Brandeis University in Massachusetts, who signed the letters to the FDA and CMS.

"The problem isn't that the test has weak specificity and sensitivity," Kolodny told MedPage Today. "The problem is that it doesn't work at all. It's 100% bogus."

The AvertD test will harm people, Kolodny emphasized. "Patients who test negative, and their clinicians, will be left with a false sense of security, which can result in overuse of opioids and addiction," he said.

"Patients who test positive will be falsely branded as prone to a highly stigmatized condition," he continued. "And they may become fearful of taking opioids, even in situations where use is beneficial."

Genetic tests for opioid addiction have a checkered historyopens in a new tab or window. The FDA approval of AvertD last year was an industry first.

Like many genetic tests, confounding is part of the problem, Kolodny and colleagues said. An independent evaluationopens in a new tab or window using methodology like the one used to test AvertD found that the algorithm gave the appearance of predicting genetic risk but was not a true measure of genetic risk, they noted.

"With proper controls for ancestry, genetic predictors from the 15 variants used in AvertD did not predict risk of OUD any better than chance," they said in their letters to the FDA and CMS.

SOLVD Health said it was aware of the letters to FDA and CMS and is reviewing them.

"We believe the FDA approval of AvertD represents a significant step forward in helping clinicians and patients have informed discussions about opioid-sparing techniques or alternative pain management options, if medically appropriate," the company said in an email to MedPage Today.

"Consistent with regulatory guidelines and standards, AvertD was clinically validated through a blinded, multicenter study evaluating participants at least 1 year after their initial exposure to prescription oral opioids," SOLVD noted. "In the hands of physicians, the test results can be a critical tool to help combat opioid use disorder."

The company also said it is conducting prospective post-market studies to further evaluate the test's performance in real-world settings.

https://www.medpagetoday.com/neurology/opioids/109508

Paxlovid Fails to Shorten COVID in Standard-Risk and Vaccinated At-Risk Patients

 Nirmatrelvir/ritonavir (Paxlovid) failed to shorten COVID-19 symptom duration among people at standard risk for severe COVID-19 and among vaccinated people with at least one risk factor for severe disease, according to final results of the phase II/III EPIC-SR

opens in a new tab or window trial.

In vaccinated and unvaccinated patients with COVID-19 at standard risk for severe disease and in fully vaccinated people with at least one risk factor who took nirmatrelvir/ritonavir, the median time to alleviation of COVID-19 symptoms was 12 days, compared with 13 days in patients who took a placebo (P=0.60), reported Jennifer Hammond, PhD, development head of antivirals at Pfizer in Collegeville, Pennsylvania, and colleagues in the New England Journal of Medicineopens in a new tab or window.

"The usefulness of nirmatrelvir-ritonavir in patients who are not at high risk for severe COVID-19 has not been established," the authors wrote.

There was a trend toward fewer hospitalizations and death among participants who took nirmatrelvir/ritonavir, where five (0.8%) of these participants were hospitalized for COVID-19 or died from any cause, compared with 10 (1.6%) of those in the placebo group through day 28 (95% CI −2.0 to 0.4). However, the difference did not reach statistical significance.

In a subgroup analysis of at-risk participants only, three (0.9%) of the participants receiving nirmatrelvir/ritonavir were hospitalized or died versus seven (2.2%) in the placebo group (95% CI -3.3 to 0.7).

In 2022, the drug's manufacturer Pfizer announced an updated interim analysisopens in a new tab or window of the EPIC-SR that reached similar conclusions to these final results. Because of low rates of hospitalization in the study population, Pfizer ended enrollment in EPIC-SR at that time.

In contrast to EPIC-SR, the EPIC-HRopens in a new tab or window trial that enrolled high-risk unvaccinated participants found that nirmatrelvir/ritonavir reduced hospitalization or death by 88%.

"What can we conclude from these two trials about nirmatrelvir-ritonavir for the treatment of COVID-19?" wrote Rajesh Gandhi, MD, and Martin Hirsch, MD, of Massachusetts General Hospital and Harvard Medical School in Boston, in an accompanying editorialopens in a new tab or window.

"Clearly, the benefit observed among unvaccinated high-risk persons does not extend to those at lower risk for severe COVID-19," they noted. The EPIC-SR results add support to current recommendationsopens in a new tab or window that nirmatrelvir/ritonavir is only indicated for treatment of mild-to-moderate COVID-19opens in a new tab or window in persons at high risk for disease progression, they said.

However, Gandhi and Hirsch also pointed out that although the EPIC-SR trial failed to show that nirmatrelvir/ritonavir shortened COVID-19 symptoms in vaccinated participants with at least one risk factor, the study enrolled only a small percentage of patients who were most likely to be hospitalized with COVID-19.

"Other than obesity, smoking, and hypertension, risk factors for severe COVID-19 were uncommon; for example, less than 2% of the participants had heart or lung disease," they wrote. Of note, only 5% of EPIC-SR enrollees were 65 years or older.

"As with many medical interventions, there is likely to be a gradient of benefit for nirmatrelvir–ritonavir, with the patients at highest risk for progression most likely to derive the greatest benefit," Gandhi and Hirsch commented.

About 26% of participants who received nirmatrelvir/ritonavir experienced an adverse event, similar to the 24.1% in the placebo group. The most commonly reported treatment-related adverse events among those who took nirmatrelvir/ritonavir were dysgeusia (5.8%) and diarrhea (2.1%). In participants receiving nirmatrelvir/ritonavir, 3.7% reported grade 3 or 4 adverse events versus 3.9% in the placebo group. No grade 5 adverse events occurred in the treatment group.

Of note, symptom rebound at day 14 occurred in 11.4% of participants treated with nirmatrelvir/ritonavir versus 16.1% in the placebo group. Viral load rebound at day 14 was similar between the 2 groups (4.3% in the nirmatrelvir/ritonavir group vs 4.1% in the placebo group).

The EPIC-SR trial included 1,296 participants who had confirmed COVID-19 and symptom onset within the previous 5 days. Participants were randomized 1:1 to receive either nirmatrelvir/ritonavir (n=654) or placebo (n=634). Participants recorded COVID-19 symptoms on a daily basis from day 1 through day 28.

The primary end point of the study was time to sustained alleviation of all targeted COVID-19 signs and symptoms. COVID-19-related hospitalization and death from any cause were also assessed through day 28. A total of 1,250 participants completed efficacy and safety follow-up assessments.

Of participants, 54% were women and the median age was 42 years. The majority of participants were white (78.5%) and 41.4% were Hispanic or Latino. Approximately 57% had been vaccinated for COVID-19, and about 50% had at least one risk factor for severe COVID-19. The most common comorbidity was hypertension (12.3%) and the most common risk factor was cigarette smoking (13.3%).

Most participants (72.5%) underwent randomization within 3 days after symptom onset. Adherence to nirmatrelvir/ritonavir -- defined as having taken at least 80% of the pills -- was nearly 95%.

Disclosures

The study was funded by Pfizer.

Hammond is an employee of Pfizer and reported holding stock options in Pfizer. Co-authors are employees of Pfizer or reported other ties to industry.

Gandhi and Hirsch reported no disclosures.

Primary Source

New England Journal of Medicine

Source Reference: opens in a new tab or windowHammond J, et al "Nirmatrelvir for vaccinated or unvaccinated adult outpatients with COVID-19" New Engl J Med 2024; DOI: 10.1056/NEJMoa2309003.

Secondary Source

New England Journal of Medicine

Source Reference: opens in a new tab or windowGandhi RT, Hirsch M "Treating acute COVID-19 -- final chapters still unwritten" New Engl J Med 2024; DOI: 10.1056/NEJMe2402224.

https://www.medpagetoday.com/infectiousdisease/covid19/109486

Risk Factors in the Development of Strokes Among Young Adults

 

Michelle H. Leppert,

 

Sharon N. Poisson,

 

Sharon Scarbro,

 

Krithika Suresh,

 

Lynda D. Lisabeth,

 

Jukka Putaala,

 

Lee H. Schwamm,

 

Stacie L. Daugherty,

 

Cathy J. Bradley,

 

James F. Burke and

 

P. Michael Ho

https://doi.org/10.1161/CIRCOUTCOMES.123.010307

Abstract

BACKGROUND:

Despite women having fewer traditional risk factors (eg, hypertension, diabetes), strokes are more common in women than men aged ≤45 years. This study examined the contributions of traditional and nontraditional risk factors (eg, migraine, thrombophilia) in the development of strokes among young adults.

METHODS:

This retrospective case-control study used Colorado’s All Payer Claims Database (2012–2019). We identified index stroke events in young adults (aged 18–55 years), matched 1:3 to stroke-free controls, by (1) sex, (2) age±2 years, (3) insurance type, and (4) prestroke period. All traditional and nontraditional risk factors were identified from enrollment until a stroke or proxy-stroke date (defined as the prestroke period). Conditional logistic regression models stratified by sex and age group first assessed the association of stroke with counts of risk factors by type and then computed their individual and aggregated population attributable risks.

RESULTS:

We included 2618 cases (52% women; 73.3% ischemic strokes) and 7827 controls. Each additional traditional and nontraditional risk factors were associated with an increased risk of stroke in all sex and age groups. In adults aged 18 to 34 years, more strokes were associated with nontraditional (population attributable risk: 31.4% men and 42.7% women) than traditional risk factors (25.3% men and 33.3% women). The contribution of nontraditional risk factors declined with age (19.4% men and 27.9% women aged 45–55 years). The contribution of traditional risk factors peaked among patients aged 35 to 44 years (32.8% men and 39.7% women). Hypertension was the most important traditional risk factor and increased in contribution with age (population attributable risk: 27.8% men and 26.7% women aged 45 to 55 years). Migraine was the most important nontraditional risk factor and decreased in contribution with age (population attributable risk: 20.1% men and 34.5% women aged 18–35 years).

CONCLUSIONS:

Nontraditional risk factors were as important as traditional risk factors in the development of strokes for both young men and women and have a stronger association with the development of strokes in adults younger than 35 years of age.

https://www.ahajournals.org/doi/10.1161/CIRCOUTCOMES.123.010307