What Elizabeth Holmes did wrong

 CNN:

Elizabeth Holmes, the former CEO and founder of failed blood testing startup Theranos, was found guilty on four charges of defrauding investors…

She was found not guilty on three additional charges concerning defrauding patients and one charge of conspiracy to defraud patients. The jury returned no verdict on three of the charges concerning defrauding investors, and Judge Edward Davila, who is presiding over the case, is expected to declare a mistrial on those charges.

The charges Holmes was found guilty of include one count of conspiracy to defraud investors, as well as three wire fraud counts tied to specific investors. Holmes faces up to 20 years in prison as well as a fine of $250,000 plus restitution for each count.

Make no mistake – Elizabeth Holmes has been found guilty of serious crimes and should be punished accordingly. But my highly cynical, perhaps world-weary take is this: They got her on wire fraud related to lying to her investors. They did not find her guilty of trying to kill people via faulty medical tests and equipment. So, let’s think about what she did in the context of the investment fraud. Should there be future trials about endangering patients (and, undoubtedly, there will be), she should be 100% held responsible if found guilty. But that’s not what happened this week.

My friend Jim Chanos has quipped that we are living through “a golden age of fraud.” The golden part is that a lot of guys (all guys) have been able to make outrageous claims, in full public view, and then get enough runway (time, money) to see those claims go from being bullshit to reality. The “fake it til you make it” ethos has literally led to trillions of dollars in market capitalization. Even in situations where regulators (or fed up investors) had been able to step in and force a founder to step down – think WeWork, Uber – the end result is still hundreds of millions or even billions of dollars accumulated, regardless of all the bad press and legal maneuvering. Adam Neumann’s grandchildren will never work again. Even the schmuck from Nikola – post lawsuits and prosecution – will probably be living in a nicer house than you are right now. There’s just so much money involved…

Elizabeth Holmes was doing something worse than pretending a car could drive itself, or putting people into unlicensed taxis with unvetted drivers hoping for the local laws to change, or outrageously double-dealing against investors in real estate deals. Her fraud was committed in the medical arena, which is more directly “life or death” in the eyes of society. This is the first thing she did very wrong and why she’s being treated more harshly than so many others. It’s not cute. It’s not “Ohhhh you little scoundrel you!” It’s f***ed up.

Importantly, that was not what the jury said she did. The guilty charges were all related to investment crimes, not patient-related crimes.

Some other stuff she did to earn a harsher prosecution and, potentially a tougher sentence:

Ripping off rich people. This was Madoff’s big mistake. You steal from the poor, you have a better shot at skating. You steal from the wealthy and they pull levers. Not only the wealthy – she also stole from powerful people – a General and a former Secretary of State and some famous venture capital titans. And, for this crowd, worse than losing money is losing respect. She humiliated her entire board and shareholder base. They publicly promoted her. It was a fiasco. She had to pay.

Not enough runway. Had she another 18 months and an extra $500 million, maybe she pivots toward something testing related the company actually can do. Maybe they “learned from their earlier trials” with the original product they were selling and finally got it right. Maybe there was a recall because some of the equipment they shipped to Walgreens was faulty but wait! Here’s the fix! Who is to say that with more time and money she couldn’t be running a massive public company right now? All I’m saying is, we’ve seen it before. Sad but true.

Too obvious. Her story was too good to be true. Her fake voice was too ridiculous to not want to poke around further. There was a journalist who bravely and meticulously dismantled her entire story for all the world to see in the Wall Street Journal. If not for his work, she may have gotten away with a lot. If your investors eventually make money, they probably don’t come after you for stuff that happened beforehand. Why would they? They’re shareholders – if the stock is up they become as stoic about the murky origin story as an Easter Island statue.

Girlboss. This is probably the most controversial part of my take, but I feel the same way about some aspects of this as I did about Martha Stewart going to jail for a tiny insider trade while so many professional investors didn’t. Something about seeing all these billionaire boys faking their way toward legitimacy while she potentially does 20 years on some of these charges doesn’t sit right with me.

She’s a criminal. She committed a crime. But the backdrop against which she made this attempt should be taken into account. The backdrop, once again, is a golden age of fraud. She was charged with lying to investors and found guilty. In other corners of the public and private stock markets, this would be (and has been) spun as “exaggerating.” I don’t want her to be excused. I just feel like everyone else should be treated similarly. If you’re fining some executives while lighting her up on a pyre, and your reasoning is that patients are involved…I’m not sure that’s how the law works. Or ought to work.

Joshua M. Brown is a New York City-based financial advisor at Ritholtz Wealth Management LLC. I help people invest and manage portfolios for them.  For disclosure information please see here.

https://thereformedbroker.com/2022/01/05/what-elizabeth-holmes-did-wrong/

Do you need another COVID-19 booster?

 As the U.S. enters its third year of the pandemic, COVID-19 cases are at an all-time high thanks to the highly transmissible omicron variant.

Unlike earlier phases of the pandemic, large-scale government interventions such as lockdowns and business closures have fallen off—even as the country logs record-breaking caseloads by the day. Health officials and the public at large are now leaning heavily on the protections conferred by the vaccines to keep hospitalizations and deaths at bay.

That's why many are scrambling to get boosted. But those with compromised immune systems fear a second or third shot may not induce an immune system response adequate to provide protection, leading some to seek out unauthorized fourth—and even fifth—shots.

With the rise in omicron, U.S. officials have been talking about the need for a second booster, or a fourth shot, to follow the two-dose regimen of Pfizer-BioNTech or Moderna plus the initial booster. Which begs the question: Is it possible to overstimulate the immune system with too many jabs?

"Theoretically, if you give too many vaccines in too short a time period, it can decrease or dampen the immune response, rather than increase it," says Todd Brown, vice chair of the Department of Pharmacy and Health Systems at Northeastern. That means that the immune system may be less likely to respond to other threats due to the repeated activation, Brown says.

Both types of shots—messenger RNA (mRNA) and viral vector—work to get the immune system to recognize a threat without actually infecting a person with a virus or other pathogen. The Pfizer-BioNTech and Moderna vaccines, which are mRNA vaccines, teach cells to create a portion of the coronavirus spike protein, which then triggers the immune system to respond so that it's ready if the real virus shows up. The single-dose Johnson & Johnson vaccine, which is a viral vector vaccine, trains the body's defense network in a similar way, but uses a deactivated virus to do so instead of genetic material.

In order for the immune system to recognize and ward off the actual coronavirus, it must have a reserve of memory lymphocytes, called the B cells and T cells. The vaccinated immune system uses these cells to help create neutralizing antibodies. Once the vaccine has trained the immune system, these memory cells remain dormant in the body for long periods of time.

"What you want is to get the 'memory' part of your immune system to work, so the B cells and the T cells," Brown says. "Your immune system is not just antibodies."

How long these antibodies last, and whether a person is capable of producing them in the first place, all depends on immune system function. Some immunocompromised patients, despite being "triple vaxxed," still haven't been able to produce enough antibodies to ward off the virus. These concerns and others have led some people to find creative, albeit unauthorized, ways to receive added doses within relatively short periods of time, the New York Times reported on Monday, which goes against the current guidance by the Centers for Disease Control and Prevention.

But elsewhere in the world, new research is emerging about the potential efficacy of a second booster. On Sunday, Israel approved a fourth jab in the 60-plus population, which would be administered four months after the third shot. Israeli officials on Tuesday shared preliminary evidence from a study showing that the fourth shot generated "a fivefold jump" in antibody production one week after administration.

Some public health officials have criticized the move as premature, adding that further allocation of boosters would divert resources away from efforts to provide shots to underserved parts of the world. Also, there is not enough evidence supporting a change in the current guidance in the U.S., says Mansoor Amiji, university distinguished professor of pharmaceutical sciences and chemical engineering at Northeastern.

The safety and efficacy of a second booster remains an open question, Amiji says, noting that there are more risks associated with repeated boosting in shorter periods of time, including dampening the immune response. That means fewer T cells and B cells, and less antibody production.

"The concern is when you start to dose these vaccines at a very short frequency, not only will your cells be exposed to a lot more mRNA than usual, but there are potential adverse side-effects," Amiji says. "Depending on how many of these doses you administer, you could risk building a tolerance" to the vaccines.

https://medicalxpress.com/news/2022-01-covid-booster.html

US hospitals seeing different kind of COVID surge this time

 Hospitals across the U.S. are feeling the wrath of the omicron variant and getting thrown into disarray that is different from earlier COVID-19 surges.

This time, they are dealing with serious staff shortages because so many health care workers are getting sick with the fast-spreading variant. People are showing up at emergency rooms in large numbers in hopes of getting tested for COVID-19, putting more strain on the system. And a surprising share of patients—two-thirds in some places—are testing positive while in the hospital for other reasons.

At the same time, hospitals say the patients aren't as sick as those who came in during the last surge. Intensive care units aren't as full, and ventilators aren't needed as much as they were before.

The pressures are neverthless prompting hospitals to scale back non-emergency surgeries and close wards, while National Guard troops have been sent in in several states to help at medical centers and testing sites.

Nearly two years into the pandemic, frustration and exhaustion are running high among health care workers.

"This is getting very tiring, and I'm being very polite in saying that," said Dr. Robert Glasgow of University of Utah Health, which has hundreds of workers out sick or in isolation.

Registered nurse Emily Yu, left, talks to Paul Altamirano, a 50-year-old COVID-19 patient, at Providence Holy Cross Medical Center in Los Angeles, Dec. 13, 2021. Hospitals across the U.S. are feeling the wrath of the omicron variant and getting thrown into disarray that is different from earlier COVID-19 surges. Credit: AP Photo/Jae C. Hong, File

About 85,000 Americans are in the hospital with COVID-19, just short of the delta-surge peak of about 94,000 in early September, according to the Centers for Disease Control and Prevention. The all-time high during the pandemic was about 125,000 in January of last year.

But the hospitalization numbers do not tell the whole story. Some cases in the official count involve COVID-19 infections that weren't what put the patients in the hospital in the first place.

Dr. Fritz François, chief of hospital operations at NYU Langone Health in New York City, said about 65% of patients admitted to that system with COVID-19 recently were primarily hospitalized for something else and were incidentally found to have the virus.

At two large Seattle hospitals over the past two weeks, three-quarters of the 64 patients testing positive for the coronavirus were admitted with a primary diagnosis other than COVID-19.

Patient Fred Rutherford, of Claremont, N.H., who is recovering from COVID-19, speaks on a telephone with a reporter from The Associated Press from an isolation room at Dartmouth-Hitchcock Medical Center, in Lebanon, N.H., Monday, Jan. 3, 2022. Hospitals like this medical center, the largest in New Hampshire, are overflowing with severely ill, unvaccinated COVID-19 patients from northern New England. If he returns home, Rutherford said, he promises to get vaccinated and tell others to do so, too. Credit: AP Photo/Steven Senne

Joanne Spetz, associate director of research at the Healthforce Center at the University of California, San Francisco, said the rising number of cases like that is both good and bad.

The lack of symptoms shows vaccines, boosters and natural immunity from prior infections are working, she said. The bad news is that the numbers mean the coronavirus is spreading rapidly, and some percentage of those people will wind up needing hospitalization.

This week, 36% of California hospitals reported critical staffing shortages. And 40% are expecting such shortages.

Some hospitals are reporting as much as one quarter of their staff out for virus-related reasons, said Kiyomi Burchill, the California Hospital Association's vice president for policy and leader on pandemic matters.

In response, hospitals are turning to temporary staffing agencies or transferring patients out.

Edward Merrens, chief clinical officer at Dartmouth-Hitchcock Health, visits COVID-19 patient Fred Rutherford, of Claremont, N.H., right, at Dartmouth-Hitchcock Medical Center, in Lebanon, N.H., Monday, Jan. 3, 2022. Hospitals like this medical center, the largest in New Hampshire, are overflowing with severely ill, unvaccinated COVID-19 patients from northern New England. If he returns home, he said, Rutherford promises to get vaccinated and tell others to do so, too. Credit: AP Photo/Steven Senne

University of Utah Health plans to keep more than 50 beds open because it doesn't have enough nurses. It is also rescheduling surgeries that aren't urgent. In Florida, a hospital temporarily closed its maternity ward because of staff shortages.

In Alabama, where most of the population is unvaccinated, UAB Health in Birmingham put out an urgent request for people to go elsewhere for COVID-19 tests or minor symptoms and stay home for all but true emergencies. Treatment rooms were so crowded that some patients had to be evaluated in hallways and closets.

As of Monday, New York state had just over 10,000 people in the hospital with COVID-19, including 5,500 in New York City. That's the most in either the city or state since the disastrous spring of 2020.

New York City hospital officials, though, reported that things haven't become dire. Generally, the patients aren't as sick as they were back then. Of the patients hospitalized in New York City, around 600 were in ICU beds.

Edward Merrens, a chief clinical officer, is interviewed by The Associated Press, in the COVID-19 Intensive Care Unit at Dartmouth-Hitchcock Medical Center, in Lebanon, N.H., Monday, Jan. 3, 2022. Hospitals like this medical center, the largest in New Hampshire, are overflowing with severely ill, unvaccinated COVID-19 patients from northern New England. Credit: AP Photo/Steven Senne

"We're not even halfway to what we were in April 2020," said Dr. David Battinelli, the physician-in-chief for Northwell Health, New York state's largest hospital system.

Similarly, in Washington state, the number of COVID-19-infected people on ventilators increased over the past two weeks, but the share of patients needing such equipment dropped.

In South Carolina, which is seeing unprecedented numbers of new cases and a sharp rise in hospitalizations, Gov. Henry McMaster took note of the seemingly less-serious variant and said: "There's no need to panic. Be calm. Be happy."

Amid the omicron-triggered surge in demand for COVID-19 testing across the U.S., New York City's Fire Department is asking people not to call for ambulance just because they are having trouble finding a test.

In Ohio, Gov. Mike DeWine announced new or expanded testing sites in nine cities to steer test-seekers away from ERs. About 300 National Guard members are being sent to help out at those centers.

Register nurse Rachel Chamberlin, of Cornish, N.H., left, assists COVID-19 patient Fred Rutherford, of Claremont, N.H., in an isolation room at Dartmouth-Hitchcock Medical Center, in Lebanon, N.H., Monday, Jan. 3, 2022. Hospitals like this medical center, the largest in New Hampshire, are overflowing with severely ill, unvaccinated COVID-19 patients from northern New England. If he returns home, Rutherford said, he promises to get vaccinated and tell others to do so, too. Credit: AP Photo/Steven Senne

In Connecticut, many ER patients are in beds in hallways, and nurses are often working double shifts because of staffing shortages, said Sherri Dayton, a nurse at the Backus Plainfield Emergency Care Center. Many emergency rooms have hours-long waiting times, she said.

"We are drowning. We are exhausted," Dayton said.

Doctors and nurses are complaining about burnout and a sense their neighbors are no longer treating the pandemic as a crisis, despite day after day of record COVID-19 cases.

"In the past, we didn't have the vaccine, so it was us all hands together, all the support. But that support has kind of dwindled from the community, and people seem to be moving on without us," said Rachel Chamberlin, a nurse at New Hampshire's Dartmouth-Hitchcock Medical Center.

Edward Merrens, chief clinical officer at Dartmouth-Hitchcock Health, said more than 85% of the hospitalized COVID-19 patients were unvaccinated.

Several patients in the hospital's COVID-19 ICU unit were on ventilators, a breathing tube down their throats. In one room, staff members made preparations for what they feared would be the final family visit for a dying patient.

One of the unvaccinated was Fred Rutherford, a 55-year-old from Claremont, New Hampshire. His son carried him out of the house when he became sick and took him to the hospital, where he needed a breathing tube for a while and feared he might die.

If he returns home, he said, he promises to get vaccinated and tell others to do so too.

"I probably thought I was immortal, that I was tough," Rutherford said, speaking from his hospital bed behind a window, his voice weak and shaky.

But he added: "I will do anything I can to be the voice of people that don't understand you've got to get vaccinated. You've got to get it done to protect each other."

https://medicalxpress.com/news/2022-01-hospitals-kind-covid-surge.html

California to extend indoor mask mandate until mid-February

 California's indoor mask mandate was extended into mid-February to help prevent the astonishing spike in coronavirus cases from overwhelming hospitals but the state's health director said Wednesday additional restrictions are not being considered.

The fast-spreading omicron variant of COVID-19 is sidelining exposed or infected health care workers, leading to hospital staffing shortages that could become a bigger problem.

"We are and continue to be concerned about our hospitals," said Health and Human Services Secretary Dr. Mark Ghaly. "Some facilities are going to be strapped."

California's confirmed cases have shot up nearly 500% in the last two weeks and hospitalizations have doubled since Christmas to more than 8,000. State models forecast hospitalizations could top 20,000 by early next month, a level nearly as high as last January, when California experienced its deadliest surge.

California had the lowest per-capita case rate in the U.S. in September, but like the rest of the country it's now experiencing a dramatic rise from the new variant. It now ranks 29th in new cases per capita over the past two weeks.

Public Health officials across the state advised residents to avoid visiting emergency rooms for COVID-19 tests or treatment that could be handled by a family doctor, telemedicine or at urgent care clinics. California had the lowest per-capita case rate in the U.S. in September, but like the rest of the country it's now experiencing a dramatic rise from the new variant.

People line up at a COVID-19 testing center Wednesday, Jan. 5, 2022, in San Fernando, Calif. Credit: AP Photo/Marcio Jose Sanchez

In Fresno County, more than 300 workers at area hospitals were out recovering from COVID-19 or isolating because of exposure to the virus, said Dan Lynch, the county's emergency medical services director. Ambulance personnel will likely be asked to assess patients and only transport people with true emergencies to ER departments.

Dr. Rais Vohra, Fresno County's interim health officer, said staff are battle hardened and accustomed to stretching resources.

"But this surge threatens even that very fragile balance that's being struck at our hospitals," he said.

The Los Angeles County Fire Department is driving patients to hospitals in fire trucks rather than ambulances because 450 firefighters are absent after testing positive, acting Assistant Chief Brian Bennett told the Carson City Council on Tuesday, according the Los Angeles Daily News.

Ivan Montoya and wife Fabiola wait in line to be tested for the COVID-19 virus at a testing site on Balboa Blvd and Saticoy St in Van Nuys, Tuesday, Jan 4, 2022. The couple who live in Arkansas came to Los Angeles to care for Ivan's mother who had the virus but has recovered. Credit: Hans Gutknecht/The Orange County Register via AP

The Grammy Awards, scheduled for Jan. 31 in Los Angeles, were postponed indefinitely Wednesday because of health and safety concerns and the NFL said it was looking into alternative sites for next month's Super Bowl scheduled in LA.

While the league finds back-up venues every year, it could come into play if there are attendance restrictions.

Ghaly encouraged unvaccinated people to get inoculated and others to get booster shots if they haven't already received one to either prevent or lessen the impact of an infection. He said the vaccines and therapeutics to treat COVID-19 are all part of an approach largely absent a year ago and there is no discussion of further restrictions.

Los Angeles said it would begin requiring employers to equip workers in close quarters indoors with medical grade masks by Jan. 17.

People line up at a COVID-19 testing center Wednesday, Jan. 5, 2022, in San Fernando, Calif. Credit: AP Photo/Marcio Jose Sanchez

As the number of COVID-19 cases surges in California, Gov. Gavin Newsom and state officials are facing criticism for failing to deliver on a promise to provide rapid, at-home tests to all California students and school staff before classrooms reopened after the winter break.

Millions of test kits were sent to families before and during winter break but millions more were not—raising concerns about public school safety now that the state's 6 million K-12 students are returning to classrooms amid soaring rates of COVID-19 cases.

Ghaly defended the state's efforts saying that by Wednesday some 6.2 million tests had been delivered to county offices of education, with more tests going out this week, despite of a variety of logistical challenges and delays caused in part by winter storms. The delivery of tests was plagued in particular by bad weather in Southern California, Ghaly said, "where we lost hundreds of thousands, even millions, of tests due to rain." He did not elaborate.

It remained unclear when the tests delivered most recently to county offices would reach school districts and then be distributed to cover all of California's 6 million K-12 public school students and the teachers and staff at California's 10,000 schools.

A few days before Christmas, Newsom announced a plan to furnish all schools with enough rapid test kits to ensure students and staff could safely return to campuses "knowing that they have not contracted the disease over the holidays," Newsom said at the time.

About half of those test kits were delivered to local governments and school districts last week. Others never arrived, California schools chief Tony Thurmond told reporters on Wednesday.

Thurman called the delay "disappointing."

"We have 10,000 schools in the state so it's a daunting task, but we've got to find ways to make it happen in a more accelerated way," he said.

In an editorial published Tuesday, the Los Angeles Times asked: Where are all the COVID-19 tests that Newsom promised for K-12 schools?

"Too many California kids went back to school this week without knowing whether they're spreading the highly contagious Omicron variant," the editorial said.

In schools that did get the tests, the results have helped prevent many coronavirus-carrying students and staff from entering campuses.

The Oakland Unified School District said Tuesday that more than 900 students and staff tested positive before the start of school Monday and were staying at home.

About half the cases were detected by testing at school sites during the holidays and the other half from rapid at-home tests that had been distributed to students before and during the break.

Sacramento City Unified School District reported that more than 500 students and staff were quarantined after testing positive for COVID-19. The district said it received about 38,000 test kits in December from the Department of Public Health, which was not enough to cover its 40,000 students and thousands more teachers and staff.

"Unfortunately the district did not receive enough kits for all students as we had expected, therefore distribution was focused on ensuring that younger populations ineligible to receive the vaccine were prioritized," the district said in a statement.

In San Francisco, 406 of about 3,600 teachers were absent for a second day Tuesday after classrooms reopened.

On a typical day prior to the pandemic, between 250 and 300 teachers would be absent for medical or other reasons.

https://medicalxpress.com/news/2022-01-california-indoor-mask-mandate-mid-february.html

COVID-infected mothers' breastmilk provides infants with antibodies

 

Figure 1. Temporal dynamics of milk anti-RBD IgA. (A) Proportion of women with milk anti-RBD IgA. (B) Concentration of milk anti-RBD IgA. The gray lines represent individuals (n=26); bolded lines represent the group LOESS curves; and horizontal dashed red line denotes the cutoff for assay positivity/limit of antigen-specific binding. Credit: DOI: 10.3389/fimmu.2021.801797

Mothers who breastfeed provide antibodies to their infants that can provide natural protection against the coronavirus that causes COVID-19, a team of researchers reported.

The new report expands earlier findings that showed the milk of breastfeeding women infected with SARS-CoV-2 did not contain the virus.

Their results support recommendations encouraging lactating women to continue breastfeeding during and after COVID-19 illness, the researchers said.

The expanded study included more than 60 women who provided samples up to two months after their COVID-19 diagnoses, said Michelle K. "Shelley" McGuire of the University of Idaho. She led the study with University of Rochester Medical Center colleague Antti E. Seppo.

The team included researchers from the U of I; Washington State University; University of Rochester Medical Center; University of California, San Francisco; Brigham and Women's Hospital; University of Arkansas for Medical Sciences; and Tulane University. The journal Frontiers in Immunology published their report Dec. 23.

"What was really important was those antibodies remained elevated in most of those women for up to two months," McGuire said. "It just added confidence that even if you have COVID, breastfeeding is the right thing to do."

The team tested the breastmilk samples for immunoglobulin A antibodies specific to the spike protein in the novel coronavirus responsible for the pandemic.

The tests showed three-quarters of the women continued to produce the antibodies in breastmilk for up to two months with some beginning as early as within a week of their COVID-19 diagnosis.

The researchers said the antibodies in breastmilk likely provided the women's infants with a lasting source of passive immunity.

The women also submitted swabs from breast skin before and after washing. Although no SARS CoV-2 virus was detected in milk, 29 percent of skin swabs tested positive for SARS CoV-2 genetic material (RNA) before washing. Only two of 29 swabs, 6 percent, tested positive after washing. The researchers attributed the presence of the viral RNA to coughing by the women or household sources.

The researchers stressed that they found no evidence of live virus or reason to be concerned about this finding. The bottom line stayed the same: Breastfeeding during COVID-19 is not only safe for infants, it is likely protective, McGuire said.

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Explore further

Breastfeeding mothers produce COVID-19 antibodies capable of neutralizing virus

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More information: Ryan M. Pace et al, Milk From Women Diagnosed With COVID-19 Does Not Contain SARS-CoV-2 RNA but Has Persistent Levels of SARS-CoV-2-Specific IgA Antibodies, Frontiers in Immunology (2021). DOI: 10.3389/fimmu.2021.801797

https://medicalxpress.com/news/2022-01-covid-infected-mothers-breastmilk-infants-antibodies.html

Real-world results on use of new device to treat brain aneurysms

 A recent international study led by researchers at Massachusetts General Hospital (MGH) and other institutions offers real-world results on the use of a novel device for treating brain aneurysms, or balloon-like bulges on weakened blood vessels that can rupture to cause life-threatening bleeding.

The study, which is published in Stroke, involved the use of the Woven Endobridge (WEB) device. This device consists of a tiny mesh plug that can be inserted through a vessel and placed into an aneurysm to block, or occlude, blood from going into the bulging region -- thereby stabilizing the vessel and preventing the aneurysm from rupturing. The device can also be used to stabilize previously ruptured aneurysms.

"The WEB has recently become available in the United States, and elsewhere across the globe the device has been available for a longer time -- but no large-scale study of its efficacy had yet been performed," says lead author Adam A. Dmytriw, MD, MPH, MSc, an interventional neuroradiology and endovascular neurosurgery fellow at MGH. "Thus, we founded the WorldWideWEB Consortium uniting the experience of 22 tertiary/quaternary institutions across North America, Europe, South America, and Australia."

The team found that among 671 patients with 683 brain aneurysms (26.2% previously ruptured) who were treated with the device and were followed for a median of 11 months, adequate occlusion occurred in 85.7% of aneurysms, and complete occlusion in 57.8%. Retreatment was required in 7.8% of aneurysms. Blood clot-related complications developed in 7.5% of procedures, of which only 4.0% were symptomatic and 2.0% were permanent. Bleeding complications occurred in 3.0% of procedures. No patients experienced aneurysm re-rupture after treatment.

"Patients who are not suitable for open aneurysm surgery or who have recently had a life-threatening rupture and would be at high risk for additional bleeding if treated with conventional endovascular techniques due to the need for blood thinners, now have a viable treatment option," says Dmytriw. "We hope that our results will help guide interventionalists in the appropriate use of the WEB so that patients with challenging brain aneurysms will have a safe option for care."

Addition medical institutions continue to join the consortium, which plans to conduct additional studies to assess the use of the WEB for diverse types of aneurysms and to examine potential challenges to its use.

Story Source:

Materials provided by Massachusetts General Hospital. Note: Content may be edited for style and length.

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Journal Reference:

1. Adam A. Dmytriw, Jose Danilo Bengzon Diestro, Mahmoud Dibas, Kevin Phan, Ahmad Sweid, Hugo H. Cuellar-Saenz, Sovann V. Lay, Adrien Guenego, Leonardo Renieri, Ali Al Balushi, Sri Hari Sundararajan, Joseph Carnevale, Guillaume Saliou, Markus Möhlenbruch, Justin E. Vranic, James D. Rabinov, Ivan Lylyk, Paul M. Foreman, Jay A. Vachhani, Vedran Župančić, Muhammad U. Hafeez, Caleb Rutledge, Muhammad Waqas, Vincent M. Tutino, Rawad Abbas, Yasuaki Inoue, Carolina Capirossi, Yifan Ren, Clemens M. Schirmer, Mariangela Piano, Anna Luisa Kühn, Caterina Michelozzi, Stéphanie Elens, Robert W. Regenhardt, Sherief Ghozy, Naif M. Alotaibi, Stavropoula Tjoumakaris, Robert M. Starke, Boris Lubicz, Pietro Panni, Ajit S. Puri, Guglielmo Pero, Christoph J. Griessenauer, Hamed Asadi, Mark Brooks, Julian Maingard, Ashu Jhamb, Adnan Siddiqui, Andrew F. Ducruet, Felipe C. Albuquerque, Peter Kan, Vladimir Kalousek, Pedro Lylyk, Amey Savardekar, Srikanth Boddu, Jared Knopman, Nicola Limbucci, Karen S. Chen, Mohammad A. Aziz-Sultan, Christopher J. Stapleton, Pascal Jabbour, Christophe Cognard, Aman B. Patel, Nimer Adeeb. International Study of Intracranial Aneurysm Treatment Using Woven EndoBridge: Results of the WorldWideWEB Consortium. Stroke, 2021; DOI: 10.1161/STROKEAHA.121.037609

https://www.sciencedaily.com/releases/2022/01/220106143648.htm

Risk of overactive bladder associated with med for dementia

 A study from the University of Houston College of Pharmacy, and published in the Journal of the American Geriatrics Society, has evaluated the risk of overactive bladder (OAB) as a side effect of cholinesterase inhibitor (ChEI) drugs taken for dementia and Alzheimer's disease. The research was based on the dissertation work of the study's first author Prajakta Masurkar.

Dementia is a group of symptoms associated with a decline in memory, reasoning or other thinking skills. Alzheimer's disease is the most common cause of dementia, accounting for 60%-80% of cases. ChEI drugs, including donepezil, galantamine and rivastigmine, increase communication between nerve cells to enhance cognition.

"The study found that the risk of overactive bladder varies across individual ChEIs," reports Rajender R. Aparasu, Mustafa and Sanober Lokhandwala Endowed Professor of Pharmacy and chair, Department of Pharmaceutical Health Outcomes and Policy. "Using a national cohort of older adults with dementia, we also found that donepezil was associated with a 13% increased risk of OAB compared to rivastigmine, whereas there was no differential risk of OAB with galantamine and rivastigmine."

Using Medicare data, the study examined 524,975 adults (aged 65 and older) with dementia who were users of ChEIs (donepezil 80.72%, rivastigmine 16.41%, galantamine 2.87%). The primary outcome of interest was OAB diagnosis or prescription of antimuscarinics, drugs which help correct overactive bladder, within six months of ChEI initiation.

While some studies have been conducted to evaluate the effects of all ChEIs and antimuscarinic use, few studies have been conducted regarding the effects of individual ChEIs on the risk of OAB. Previous studies have found that the use of ChEIs is associated with an increased risk of receiving an antimuscarinic drug.

This study opens a new door.

"The findings suggest the need to understand and manage medication-related morbidity in older adults with dementia," said Aparasu.

Story Source:

Materials provided by University of Houston. Original written by Laurie Fickman. Note: Content may be edited for style and length.

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Journal Reference:

1. Prajakta P. Masurkar, Satabdi Chatterjee, Jeffrey T. Sherer, Hua Chen, Michael L. Johnson, Rajender R. Aparasu. Risk of overactive bladder associated with cholinesterase inhibitors in dementia. Journal of the American Geriatrics Society, 2021; DOI: 10.1111/jgs.17579

https://www.sciencedaily.com/releases/2022/01/220106152438.htm