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Friday, January 13, 2023

20 Year Old Colorado College Tennis Player Dies Unexpectedly In His Sleep

 We hate to say it, but another day, another mysterious and unexpected death of a seemingly normal collegiate athlete. As we wrote yesterday, either there is a new focus in media on reporting about the untimely deaths of athletes and young adults, or something very odd appears to be taking place across the country.

Jack Madison, a sophomore on the Colorado College men's tennis team, passed away in his sleep on January 2nd, a new report from the Gazette, published yesterday, confirms. Colorado College vice president and director of athletics Lesley Irvine commented: "We are devastated by the tragic passing of Jack Madison."

A sought after athlete, the piece notes that Madison was recruited "out of Bexley, Ohio, where he was a two-time all-state selection at Columbus Academy." His cause of death has not been announced.

“As a community, we grieve his death and loss and hold all who cared for and loved Jack in the light during this time of grief, especially his family and friends,” the college said in a statement obtained by FOX. 

“He loved tennis and being part of CC’s tennis team, for which he was recruited. He engaged fully with campus life in a myriad of ways, embracing CC to the fullest. Jack was observant, super imaginative, creative, and independent-minded. His humor, deep thinking, and generous spirit were a gift in his friendships and to all of us," it continued.

Madison's death follows a growing list of mysterious deaths and medical episodes among young adults and athletes:

  • On January 12, 2023, we wrote about 18 year old Jordan Brister, a Las Vegas High School student who collapsed and died in the bathroom after gym class.

  • His death came the same week as the death of another Las Vegas High School student. Brister's collapse was on January 8, 2023, and another student, 16 year old Ashari Hughes, had died just three days prior "following a flag football game at Desert Oasis High School" and suffering a "medical episode". 

  • Also in the first week of January 2023, we wrote about 21 year old Air Force football player Hunter Brown, who suffered a "medical emergency" while walking to class and passed away.

  • In the opening days of 2023 the MMA world was also shocked at the unexpected death of 18 year old Victoria Lee, a rising star on the the ONE Championship MMA promotion.

  • In January 2023, we also highlighted Old Dominion basketball player Imo Essien collapsing on the court during the middle of a game.

  • His collapse came a little more than a week after NFL player Demar Hamlin collapsed on the field due to cardiac arrest after making what appeared to be a routine tackle. 

CDC, FDA Identify Covid Vaccine Safety Signal for 65 and Older

 The FDA and CDC said their safety monitoring system met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the bivalent Pfizer-BioNTech COVID-19 vaccine.

  • Detected signal raised a question about likelihood of stroke in this population in the 21 days following vaccination
  • FDA and CDC say it is “very unlikely” that signal represents true clinical risk but will continue to evaluate data
  • Signal has not been detected in Moderna vaccine
  • No other safety systems have shown a similar signal and multiple subsequent analyses have been performed.

Group Now Targeting Twitter For 'Climate Misinformation' Linked To Fusion GPS, Disinfo Campaign

 A nonprofit organization headed by an FBI analyst-turned-Democrat operative & vociferous Russiagater, Daniel Jones, has funded both Fusion GPS - the firm that laundered Hillary Clinton's funding of the infamous 'Steele Dossier' - and a study which found an increase in "climate change misinformation" on Twitter since Elon Musk bought the company.

Jones, a former staffer for Democrat Senator Dianne Feinstein (of 'Chinese spy driver' fame), founded 'Advanced Democracy,' through which he shared a study with USA Today which claims that instances of "climate fraud," "climate hoax," and "climate scam" jumped over 300% in 2022.

As the Daily Caller notes, however, Advance Democracy has also funded groups pushing now-debunked claims involving the 2016 US election, as well as a group which pushed a disinformation campaign in the 2017 Alabama special Senate election.

The non-profit in 2020 paid $140,000 to Bean LLC, the parent company of Fusion GPS, for “research consulting” services. Fusion GPS was hired by Perkins Coie, a Democrat-linked law firm retained by the Clinton campaign and the Democratic National Committee, to conduct opposition research on the Trump campaign between April 2016 and October 2016; Fusion GPS commissioned Christopher Steele to produce a now-discredited opposition research report on the Trump campaign, according to public tax filings.

Many of the Steele dossier’s allegations have been subsequently debunked and proven false.

Advance Democracy has previously funded Fusion’s parent company to the tune of $6,051,251 as of 2020, according to the Washington Examiner’s review of earlier tax filings.

Additionally, Advance Democracy paid $540,000 to the research firm Yonder, according to public tax filings; Yonder was previously known as New Knowledge, the Daily Caller News Foundation previously reported. New Knowledge CEO Jonathon Morgan reportedly participated in a disinformation operation during the 2017 Alabama special Senate election between Doug Jones and Roy Moore, ostensibly to study how Russian disinformation campaigns during the 2016 election operated, according to The New York Times. -Daily Caller

"We orchestrated an elaborate ‘false flag’ operation that planted the idea that the Moore campaign was amplified on social media by a Russian botnet," read an internal report, according to the NY Times.

Jones' group has also provided reports on 'online misinformation and disinformation' to sites such as Politico and The Washington Post to push narratives involving election misinformation and 'threats to democracy.'

https://www.zerohedge.com/political/group-now-targeting-twitter-climate-misinformation-linked-fusion-gps-disinfo-campaign

'Cancer Surgery Linked to Higher Suicide Risk'

 The incidence of suicide was significantly higher in patients undergoing cancer surgery compared with the general U.S. population, a retrospective population-based cohort study showed.

Among patients undergoing surgery for the 15 deadliest cancers in the U.S. from 2000 to 2016, the suicide rate was 14.5 per 100,000 person-years -- a rate that was significantly higher compared with the general population after adjustments for age, sex, race, and calendar year of death (standardized mortality ratio [SMR] 1.29, 95% CI 1.23-1.36), reported Chi-Fu Jeffrey Yang, MD, of Massachusetts General Hospital in Boston, and colleagues.

About half of suicides occurred within the first 3 years after surgery, while 3% and 21% occurred within the first month and first year, respectively, they noted in JAMA Oncology

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"These findings suggest the need to implement suicide screening among patients undergoing cancer operations, especially patients whose demographic and tumor characteristics are associated with the highest suicide risk," Yang and team wrote.

Specifically, compared with the general population, the incidence of suicide was statistically significantly higher among patients undergoing surgery for the following sites of cancer:

  • Larynx: SMR 4.02 (95% CI 2.67-5.81)
  • Oral cavity and pharynx: SMR 2.43 (95% CI 1.93-3.03)
  • Esophagus: SMR 2.25 (95% CI 1.43-3.38)
  • Bladder: SMR 2.09 (95% CI 1.53-2.78)
  • Pancreas: SMR 2.08 (95% CI 1.29-3.19)
  • Lung: SMR 1.73 (95% CI 1.47-2.02)
  • Stomach: SMR 1.70 (95% CI 1.22-2.31)
  • Ovary: SMR 1.64 (95% CI 1.13-2.31)
  • Brain: SMR 1.61 (95% CI 1.12-2.26)
  • Colon and rectum: SMR 1.28 (95% CI 1.16-1.40)

Patients undergoing surgery for cancers with higher 5-year overall survival rates had lower SMRs compared with patients undergoing surgery for cancers with lower 5-year rates (slope -0.022, 95% CI -0.039 to -0.004, P=0.02). Of note, patients who underwent surgery for cancers with 5-year overall survival rates greater than 80% -- such as cancers of the corpus uterus, kidney, breast, and cervix -- showed no statistically significant increased incidence of suicide relative to the general population, the authors said.

The median time from surgery to suicide varied by cancer site and ranged from 11.5 months for patients with brain cancers to 78 months for those with cervical cancers.

Patients who were male, white, and divorced or single were at greatest risk for suicide. According to Yang and colleagues, the combined effects of cancer site and patient characteristics increased suicide risk. For example, they reported that white men undergoing surgery for laryngeal cancer had a suicide rate (per 100,000 person-years) that was 63 times greater than that of Black women undergoing surgery for breast cancer.

While major medical professional societies recommend that patients with cancer be screened for distress, adherence to these recommendations is low, the authors noted. Furthermore, these screening efforts are more likely to be implemented in medical oncology practices and not surgical oncology practices, they added.

"Thus, distress screening implemented in medical oncology practices may never reach patients who undergo cancer operations," they wrote. "Further work is needed to develop and implement distress screening programs in surgical oncology practices and to ensure that such programs adequately address the unique psychosocial needs of patients undergoing cancer operations."

In an editorial accompanying the study

opens in a new tab or window, Craig J. Bryan, PsyD, ABPP, of the Ohio State University in Columbus, and colleagues noted that one in six patients have pre-existing psychiatric conditions -- conditions that are not only associated with suicide risk, but other outcomes as well, including perioperative complications, longer hospital stays, higher rates of readmission, and increased risk of postoperative suicidal ideation.

Thus, the results of this study not only emphasize the importance of screening patients with cancer for psychiatric conditions and suicide risk, but also "highlight the importance of ensuring access to evidence-based psychological and behavioral treatments both before and after cancer surgery," they wrote.

For this study, Yang and colleagues used data from the Surveillance, Epidemiology, and End Results Program database to examine the incidence and timing of suicide among patients undergoing surgery for the 15 deadliest cancers in the U.S. from 2000 to 2016.

They included 1,811,397 patients (median age 62, 74.4% women). Of these patients, 1,494 (0.08%) died by suicide after undergoing surgery for cancer.

Disclosures

Yang had no disclosures. A co-author reported a relationship with the National Institute on Drug Abuse.

Bryan reported grants from the National Institute of Mental Health and the U.S. Department of Defense, as well as personal fees from Oui Therapeutics and Anduril LLC outside the submitted work.

Primary Source

JAMA Oncology

Source Reference: opens in a new tab or windowPotter AL, et al "Incidence, timing, and factors associated with suicide among patients undergoing surgery for cancer in the US" JAMA Oncol 2023; DOI: 10.1001/jamaoncol.2022.6549.

Secondary Source

JAMA Oncology

Source Reference: opens in a new tab or windowBryan CJ, et al "Evidence-based strategies to reduce suicide mortality among patients with cancer" JAMA Oncol 2023; DOI: 10.1001/jamaoncol.2022.6373.

https://www.medpagetoday.com/hematologyoncology/othercancers/102611

Off-the-Shelf T-Cell Therapy Effective Against Viral Infections After Allo-HCT

 An investigational, off-the-shelf T-cell therapy appears to be effective against six different viral infections that are common in patients who undergo allogeneic hematopoietic cell transplantation (HCT), according to results from a phase II trial.

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Posoleucel achieved a partial or complete antiviral response in 95% of 58 adult and pediatric patients infected with one or more of the viruses within 6 weeks of the first infusion with the multi-virus-specific therapy, reported Bilal Omer, MD, of Baylor College of Medicine in Houston, and colleagues in Clinical Cancer Researchopens in a new tab or window.

"The response rate was quite high, and this is notable because these patients, for the most part, either didn't tolerate conventional therapies, or they had completely failed conventional therapies. So these were patients with pretty significant virus infections," Omer told MedPage Today. "And we were able to treat these patients quickly -- within 24 to 48 hours -- with this off-the-shelf product."

"These infections are a pretty major problem, and while we've made progress with other types of infections, there are just not a lot of effective and safe medications out there for virus infections," Omer continued. "And these patients can get pretty severe virus infections -- usually in the first 3 to 6 months after transplant -- that are the cause of both morbidity and mortality."

Omer explained that some centers have treated these patients using virus-specific T cells that are donor derived. And while effective, "these have to be individually generated for each of these patients, cost a lot of money, and take time to manufacture," limiting the broad adoption of this approach.

In this case, Omer and his colleagues used off-the-shelf T cells that were generated from healthy donors to target six viral viral pathogens in immunocompromised patients: adenovirus, BK virus, cytomegalovirus, Epstein-Barr virus, human herpesvirus-6 (HHV-6), and JC virus.

Of the 58 treated patients, about half were male (52%), and 18 (31%) were under age 18 at the time of enrollment. Transplant donor sources included matched unrelated (48%), cord blood (16%), mismatched unrelated (16%), haploidentical (10%), and matched related (10%).

Of the 70 evaluable infections treated, the majority were caused by BK virus (39%) or cytomegalovirus (34%), the researchers reported. The vast majority, 46 of the patients, had a single virus upon enrollment while 12 had two or more of the targeted viruses.

The investigators found that by 6 weeks after the initial infusion of posoleucel, partial or complete antiviral responses were achieved in 55 of the entire cohort of 58 patients -- 45 of 46 with one virus infection, and 10 of 12 patients with two or more target viruses.

Regarding specific viruses, antiviral responses were achieved in 10 of 12 patients with adenovirus, all 27 patients with BK virus, 23 of 24 patients with cytomegalovirus, both patients with Epstein-Barr virus, and three of four patients with HHV-6, with viral load reduced in the other patient as well.

The one patient with JC virus had initial stabilization of viral symptoms, which then, however, ultimately progressed, and the patient died.

Omer explained that considering that the patients received T cells from donors with human leukocyte antigen types that were different from those of the individual patients, a main safety concern was graft-versus-host disease (GVHD), which was reported in 13 patients during the trial -- grade 2 in two patients and grade 3 in one patient.

"We really didn't see any severe GVHD," he said. "We saw a couple of patients who got rashes, and those were transient -- they were signs of grade 1 skin GVHD -- but for the most part these were mild and self-limited, and we didn't see any indication that this product would cause moderate or severe GVHD."

There were no reported cases of cytokine release syndrome or other infusion-related toxicities.

The researchers noted that posoleucel is currently being evaluated in three randomized phase III trials for treatment and preventive indications.

Disclosures

The trial was sponsored by AlloVir.

Omer reported research funding from AlloVir; several co-authors reported relationships with industry.

Primary Source

Clinical Cancer Research

Source Reference: opens in a new tab or windowPfeiffer T, et al "Posoleucel, an allogeneic, off-the-shelf multivirus-specific T-cell therapy, for the treatment of refractory viral infections in the post-HCT setting" Clin Cancer Res 2023; DOI:10.1158/1078-0432.CCR-22-2415.


https://www.medpagetoday.com/hematologyoncology/hematology/102638

Florida Health Agency Issues Warning on Prescribing Abortion Pill

 This week, Florida healthcare providers received a letter from state officials warning that they should continue to comply with state abortion laws following FDA's relaxed rules on abortion medication prescribing.

According to News4JAXopens in a new tab or window, the letter from the Agency for Health Care Administration in Florida referenced several state laws that regulate access to abortion medications. For example, the notice highlighted a lawopens in a new tab or window stating that "[n]o termination of pregnancy shall be performed at any time except by a [licensed] physician."

The agency's notice also emphasized that it is "unlawful

opens in a new tab or window for any person to perform or assist in performing an abortion on a person, except in an emergency care situation, other than in a validly licensed hospital or abortion clinic or in a physician's office."

Additionally, the notice also made clear that violations of those laws could result in criminal penalties, and that the state would refer "any evidence of criminal activity" to local law enforcement, News4JAX reported.

The Agency for Health Care Administration sent the letter to healthcare providers following the recent FDA changesopens in a new tab or window made to the regulation on mifepristone (Mifeprex) that allows patients to pick up the abortion pill at brick-and-mortar retail pharmacies. Mifepristone is an abortion medication that can be used to end an intrauterine pregnancy through 10 weeks gestation.

Florida's restrictions on abortion and access to abortion medication means that healthcare providers and pharmacists in the state cannot take advantage of the FDA's recent changes and should be careful about making changes to their own practices, according to Daniel Grossman, MD, of the University of California San Francisco, and the director of Advancing New Standards in Reproductive Health.

"They need to take it very seriously," he told MedPage Today. "Given those restrictions, it wouldn't be possible to prescribe the medication at a pharmacy to be picked up or mailed directly to the patient."

Grossman emphasized that this is part of a long-term trend in many states toward limiting access to abortion services, including medication like mifepristone.

"Over the past 15 years -- but even over a longer period of time -- there have been a growing number of severe restrictions that have been imposed at the state level in many states, and some of those states have now completely banned abortion," Grossman said. "In those states where abortion is still legal, some of them continue to have these very serious restrictions."

This reality has been complicated by the national focus on access to abortion, especially with the changes to the FDA's regulation on mifepristone, Grossman said.

"Some of the reporting has been a little confusing, and almost made it sound like this was a change that affects the availability of the mifepristone nationwide, and that's not really true," Grossman said. "So physicians in those states won't be able to take advantage of this advance."

Nevertheless, residents in states with severe abortion restrictions, like Florida, may still act on FDA's changes on mifepristone in special circumstances.

For instance, "if they were near the border of a state that was allowing prescription of mifepristone perhaps they could have a telehealth visit and pick up the medication just across the border at a pharmacy," Grossman said.

https://www.medpagetoday.com/special-reports/features/102640

Anesthesia Outside of the OR: Cause for Patient Safety Concerns?

 Despite the growth in use of procedural suites outside of the operating room, non-OR anesthesia (NORA) care remains a troubling concern for patient safety, experts say.

Non-OR procedure suites -- such as cardiac catheterization labs, interventional radiology suites, or gastroenterology suites -- continue to increase in number and caseload, leading anesthesiology providers and patient safety advocates to call for improved practice standards to address growing concerns over patient safety.

For years, Emily Methangkool, MD, MPH, vice chair of quality and patient safety at the University of California Los Angeles, has been sounding the alarm at medical conferences, warning a crisis may be on the horizon as non-OR procedures are expected to grow to more than 50% of all anesthesia cases in the near future.

"Malpractice claims in NORA compared to the operating room are more commonly associated with injury from respiratory issues, for example hypoxia or hyperventilation," Methangkool told MedPage Today. "That is more common in NORA because we are sedating the patients without a protected airway, so for a lot of these cases we are not putting a breathing tube in the patient [who is getting] sedation."

What Is NORA?

NORA is broadly defined as any anesthesia care provided in a setting that is not an OR. This can include interventional cardiology suites or cardiac catheterization labs, interventional radiology suites, or gastroenterology suites where endoscopies and colonoscopies are performed. NORA can also refer to outpatient or ambulatory surgery centers, and even occasionally medical offices.

Anesthesiologists have a complicated relationship with NORA care, said Jeffrey White, MD, an associate professor of anesthesiology at the University of Florida. It's characterized by problematic case schedules, long internal commutes between the main OR and procedure suites, and the lack of access to tools typically available in the OR, he said. (See this sidebar on the challenges of delivering anesthesia care in procedural suites.)

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"It used to historically go by a bunch of other names like 'out of OR' and then, mnemonically, 'OOR,'" he said. "And not uncommonly and perhaps with a dismissive sort of epithet, it was called 'The Outback,' as if it was in Australia because you're sort of locked in the desert."

There are also concerns about the delivery of anesthesia care outside of a well-resourced OR, Methangkool said.

"Amongst anesthesiologists, it is well recognized that non-OR locations pose patient safety risks because we're working outside of the operating room with not-the-usual standards of equipment and monitoring and teamwork that we're used to," she said.

At the same time, the rapid rise in NORA has allowed specialists to treat patients who previously would have been considered too old or too sick for a longer surgery in the OR.

This combination of older sick patients undergoing new advanced procedures outside the OR -- where providers may not necessarily have the team or equipment they're used to working with, or where the anesthesia equipment might be in the wrong place -- "really poses the hazards to patient safety," said Methangkool.

Patient Safety Concerns

Patient safety concerns came to the forefront after a series of studies showed higher rates of complications and death with NORA cases versus regular OR cases.

One key studyopens in a new tab or window using claims data showed that anesthesia cases conducted in "remote" locations had a significant increase in deaths compared to cases done in the OR (54% vs 29%, P<0.001). It also found that respiratory damage and inadequate oxygenation were more common in NORA cases.

Patient safety has since become a common phrase that accompanies any mention of NORA among anesthesia providers, Methangkool said. Several anesthesia groups have worked to create talks and recommendations for how to improve patient safety in NORA cases.

In fact, the journal Current Opinion in Anesthesiology dedicated an entire issueopens in a new tab or window last year to the myriad concerns that anesthesiologists have about working on NORA cases, including a paperopens in a new tab or window detailing the need for more strategic planning, checklists, and consistent staffing models specifically to help reduce pulmonary complications.

White is an author of one of those papers, but he acknowledged that not all studiesopens in a new tab or window have shown greater harm with NORA. Nonetheless, he said the logistics of NORA alone are a constant cause for concern among anesthesiologists.

"These patients are really too sick to have a big major open operation," he said, "Well, if they're too sick to be in the main OR, that does not reduce the risks, and so that became the issue."

In addition to treating higher-risk patients, anesthesia providers have also expressed concern about the environment of procedural suites. Methangkool noted that anesthesia providers are often stuck with suboptimal conditions, either due to a lack of space for anesthesia equipment or poor positioning for an anesthesia provider in relation to the patient.

"They didn't necessarily build [procedural suites] with anesthesia in mind," Methangkool said. "It's super, super important for patient safety."

Benefits of Procedural Suites

The flip side of patient safety concerns are the potential benefits to patients, said Aasma Shaukat, MD, MPH, a gastroenterologist at NYU Langone Health.

In gastroenterology, for instance, about 16 million colonoscopies and 18 million upper endoscopies are performed each year, Shaukat said. "We do them very well, very efficiently, they're safe, and they give us a variety of information for diagnostic purposes," she added.

The benefit of these procedures for patients is clear, but the sheer quantity in the gastroenterology suite has contributed to the additional pressure on anesthesia providers, Methangkool said.

Still, Shaukat said the need for anesthesia providers is relatively new, especially for colonoscopies. Colonoscopies used to be performed with moderate sedation, which did not require the assistance of an anesthesia provider, but a recent trend in the use of deep sedation has changed that practice.

The catch is that gastroenterologists cannot administer deep sedation, Shaukat said. This has created a major demand for anesthesia providers in gastroenterology suites and ambulatory surgery centers.

More Collaboration Needed

Anesthesiologists and patient safety advocates want to see more collaboration between anesthesiologists and the various specialties to help identify and address areas of concern with NORA cases. Methangkool noted that these concerns might not be felt by the specialists working on the cases in the same way though.

"From the gastroenterologists' perspective, from the interventional radiologists' perspective, they probably don't see it the same way because they see it just as, 'I'm doing my case in a location that I am used to, the patient just needs sedation, what is the big deal?'" she said.

This viewpoint might mean that gastroenterologists, cardiologists, and radiologists are not aware of the risks that could present during NORA cases.

Shaukat did acknowledge that there has been some research suggesting an increase in complications in these cases, but she said the effect has been "hard to tease out" from the complexity of the patients or procedures and the administration of deep sedation. She also noted that she has not seen a significant issue with anesthesia providers not having enough space or access to patients during colonoscopies.

Shaukat emphasized that having access to anesthesia care from anesthesiologists and certified registered nurse anesthetists (CRNAs) is essential to increasing patient access to these procedures. As more patients want these procedures done with deep sedation, she said, anesthesia providers are suddenly in short supply.

Despite the bottleneck for anesthesia care, Shaukat said NORA cases are likely to continue to increase because they are beneficial to patients, and patients want these procedures using deep sedation.

"Getting [patients] good access, getting them their procedures safely but efficiently, and in a timely manner, is important to us," Shaukat said.

Methangkool noted that all specialists involved in these cases need to focus on developing checklists and guidelines together to better address these overlapping concerns about NORA and patient safety.

"I think we still need to kind of bridge that gap from understanding from the anesthesia side to the proceduralist side," she said.

"As a specialty, we're very aware of the risks that NORA poses, and I think we are trying to, I guess, publicize that to our colleagues in medicine," said Methangkool. "We're making headway in a way that we haven't in the past decade, but definitely there needs to be more recognition."

https://www.medpagetoday.com/special-reports/exclusives/102632