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Monday, June 20, 2022

Healthy lifestyle shown to decrease dementia risk up to 36 percent: study

 New evidence suggests that lifestyle factors, including diet, exercise and sleep, can significantly reduce the risk of developing dementia.

More than one-third of residents in assisted living and other residential care communities have some form of dementia or cognitive impairment, according to data from the Alzheimer’s Association.

A study from Vanderbilt University Medical Center published Monday in the American Academy of Neurology’s journal, Neurology, found an association between healthy lifestyles and the risk of Alzheimer’s disease and related dementias among socioeconomically disadvantaged Americans.

Researchers concluded that promoting healthy lifestyles and reducing barriers to lifestyle changes are crucial to tackling the growing burden and disparities posed by Alzheimer’s disease and related dementias.

Research published recently by the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report similarly examined risk factors for dementia, finding the prevalence was highest for individuals with high blood pressure and not meeting physical activity guidelines.

Vanderbilt researchers looked at data from 17,209 participants — 1,694 of whom received diagnoses of Alzheimer’s or related dementias during the four-year follow-up period.

Researchers looked at five lifestyle factors — tobacco smoking, alcohol consumption, leisure time physical activity, sleep hours and diet quality — and their effect on dementia risk.

Healthy lifestyles, they reported, were associated with an 11% to 25% reduced risk of Alzheimer’s disease and related dementias. The benefits were seen regardless of sociodemographics and history of cardiometabolic disease and depression. When combined, a composite score of those five lifestyle factors was associated with a 36% reduced risk in the highest versus the lowest quartile. 

“Our findings support the beneficial role of healthy lifestyles in the prevention of Alzheimer’s disease and related dementias among senior Americans, including those with socioeconomic disadvantages and a high risk of dementia,” study lead author Danxia Yu, Ph.D., said in a press release. “It is critical to establish public health strategies to make lifestyle modifications achievable for all, especially disadvantaged populations.”

The research is from the Southern Community Cohort Study, a long-term research study launched in 2001 to examine the root causes of various diseases and health disparities.

The study was supported by the National Institutes of Health.

https://www.mcknightsseniorliving.com/home/news/healthy-lifestyle-shown-to-decrease-dementia-risk-up-to-36-percent-study/

PTC Therapeutics Call to Review Topline Results from Duchenne Study

  PTC Therapeutics, Inc.  (NASDAQ: PTCT) will host a conference call Tuesday, June 21st at 8:00 a.m. E.T. to review topline results from Study 041 of Translarna™ (ataluren) in patients with nonsense mutation Duchenne muscular dystrophy. The call will be accompanied by a slide presentation which can be accessed through our online webcast.

The webinar can be accessed by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the webinar and providing the passcode 7033198. A live, listen-only webcast can be accessed on the Events and Presentations page under the investor relations section of PTC Therapeutics' website at www.ptcbio.com. The accompanying slide presentation will be posted on the investor relations section of the PTC website. A webcast replay will be available approximately two hours after completion of the webinar and will be archived for 30 days following the webinar.

https://www.biospace.com/article/releases/ptc-therapeutics-to-host-call-to-review-topline-results-from-study-041-for-translarna-ataluren-in-nonsense-mutation-duchenne-muscular-dystrophy/

Time for a Post-Mortem on COVID Crisis Standards of Care

 Ever since the threat of an avian flu pandemic in 2006, governments, hospitals, and professional associations have been preparing for the next "big one." New York State was a leader in pandemic preparation, having developed its Ventilator Allocation Guidelines in 2007, with updates in 2015. And yet, when the COVID tsunami hit New York City in early 2020, overwhelming the healthcare system, New York failed to revise and officially activate its guidelines, despite pleas from professional and institutional stakeholders, leaving hospital staff without guidance. Without state sanctioned activation, individual hospitals and their staff struggled to make difficult triage resuscitation decisions, in some instances without benefit of legal protection. Nevertheless, decisions at the bedside had to be made. Because as Matthew Wynia, MD, MPH, noted early on: "No one would want to be accountable for making these decisions. They're tragic decisions, which is why they roll downhill. Right? From powerful person to less powerful person to the person who can't say I refuse to make that decision. That's how they end up in the lap of the bedside doctor."

Throughout the nation, hospitals in urban and rural areas also experienced unprecedented surges in COVID and had to make difficult decisions at the bedside because they had no choice. Very little is known about these decisions. In 2022, it is time to find out.

Crisis Standards of Care

Crisis standards of care (CSC) are officially invoked by state governments when sustained demand far exceeds available hospital staff, equipment, and space. Hospitals operating at this level of capacity, i.e., crisis capacity, may be at significantly higher risk of patient morbidity and mortality. In response, CSC plans typically call for expansion of hospital capacity and for coordinated, if not centrally directed, regional sharing of resources and transfer of patients if necessary. To facilitate staffing, competency, and credentialing, regulations are relaxed. If these measures fall short, CSC allows for triage -- the prioritization of access to life-sustaining treatments (e.g., ventilators) -- aimed at saving the most lives possible. Accordingly, patients who have the greatest chance of survival with intervention receive higher priority than both those with the highest likelihood of survival without medical intervention and those with the smallest likelihood of survival even with medical intervention.

To protect the fiduciary relationship of the physicians and nurses treating the patient, triage decision making, which is supposed to be a transparent process based on publicly available criteria, should be carried out by an independent triage officer or triage team. In many states, triage is a three-step process:

  1. Initial screening of patients and possible denial of aggressive treatment based on exclusion criteria (e.g., medical conditions that result in immediate or near-immediate mortality even with aggressive therapy) or simply by positioning such patients so low on the priority list it is clear they would never receive scarce resources
  2. Risk assessment based on best available objective criteria, such as the Sequential Organ Failure Assessment (SOFA) score, and other physiological data to determine ICU admission priorities
  3. Periodic reassessment of progress at regular intervals

In New York City, hospitals dramatically expanded hospital and ICU capacity to meet the sustained surge in demand. For example, Montefiore Health System in the Bronx quadrupled its ICU beds from 120 to 475, an extraordinary expansion in capacity. In those hospitals experiencing the most extreme surges, the quality of care no doubt was diluted by an overstretched and, in many instances, inadequately trained (in critical care) staff. Decidedly, it was an "all hands on deck" approach. Could it have been any other way with cases doubling every 3 days, staff getting sick and dying because of lack of PPE, and refrigeration trucks augmenting hospital morgues? The pressure on the staff must have been unimaginable.

Morbidity and Mortality Rounds

A 2022 summary report from the Assistant Secretary for Preparedness and Response of HHS showed wide variation in the ways states and individual hospitals implemented or failed to implement their CSC plans, if they had one. Among the key findings: only 9 states declared CSC; in 15 states, crisis care apparently occurred but no official declaration was made; and many hospitals declared CSC in the absence of state action. In some states, with or without a declared CSC, executive orders provided for hospital expansion and the relaxation of credentialing requirements. John Hick, MD, et al. in their assessment of lessons learned from COVID, found that the formal CSC plans often failed to meet the needs of the situation on the ground. Also, healthcare providers often suffered from severe moral distress related to bedside rationing decisions.

What was it really like for doctors, nurses, and other healthcare professionals on the front lines? A qualitative study from Elizabeth Chuang, MD, MPH, and colleagues designed to identify potential problems in implementing model guidelines, based on the National Academies of Medicine Crisis Standards of Care and the New York State Ventilator Guidelines, found doctors and nurses to be conflicted over the ethics of triage, raising concerns about their actual performance in a pandemic. Robert Truog, MD, MA, reconsidering the soundness of the Massachusetts CSC, concluded that the basic approach was flawed and impossible to implement and that if time-limited trials of ventilators were used as a precursor to withdrawal, they would likely face backlash from politicians. Similar obstacles with regard to the implementation of CSC protocols were found in Arizona as part of a system simulation exercise (Patricia Mayer, MD, personal communication).

It is time for hospitals to hold the equivalent of morbidity and morbidity rounds to examine the formal (state or hospital) and informal/ad hoc responses to COVID surges involving triage.

We need a postmortem, and we need to start with questions.

What do we know about the CSCs and their processes? Were the state CSC triage guidelines, or the ones adopted by hospitals, helpful or too cumbersome to be useful? Were formal triage guidelines used at all? To what extent were triage decisions made in the ER and were CSC exclusion criteria useful, if they existed? What was the utility of SOFA and other scoring systems? Who actually oversaw the response to the COVID surge and triage (e.g., Incident Command System), if anyone, and with what effectiveness? In the places that formally activated triage protocols (some facilities in Alaska, Tennessee, and Idaho for instance) did they keep records? What were their results, and did they indeed save more lives using a protocol?

What do we know about outcomes? To what extent did patients die who would have survived under normal conditions? Did salvageable patients die because ICUs were already filled with dying patients because staff were unwilling or unable to withdraw life-sustaining treatment to make way for others?

What do we know about staff? To what extent did staff feel their decision making was supported legally and ethically? Did medical teams even recognize the care being provided as triage? Did teams consider or try to deal with racial inequities? How many staff were bullied, threatened, or harassed after the "heroes" label went cold? How many quit? Committed suicide? What were the reactions and consequences to teams using formal triage processes versus those triaging ad hoc?

What do we know about patients and families? How much did patients or families know about the limitations in "stuff, space, and staff"? How are families coping now when they lost loved ones they weren't allowed to see?

What is the public perception of CSC and triage? How does the public feel about states that did not activate CSC (including New York and Texas) when TV footage was filled with dying patients, morgue trucks and body bags, and literally everybody assumed somebody was making decisions?

And what lessons were learned? Specifically, what could have been done differently? How can we improve next time (and there will be a next time) -- unless we have information about what happened this time? Failure to learn from this experience dishonors those who died as well as those who served. We need answers.

Martin A. Strosberg, PhD, is emeritus professor of healthcare policy, and bioethics at Union College and Clarkson University in Schenectady, New York. Patricia Mayer, MD, is a palliative care physician and the director of clinical ethics at Banner Health based in Phoenix. Daniel Teres, MD, is a critical care physician and clinical instructor in public health and community medicine at Tufts University School of Medicine in Boston.

https://www.medpagetoday.com/opinion/second-opinions/99289

Meta Sued For Allegedly Sharing Medical Data In Secret

 Meta Platforms Inc 

 is facing a lawsuit that says people’s medical data is being secretly shared with Facebook when patients access their healthcare providers’ web portals, reports Bloomberg

According to the report, the Pixel tracking tool, which Facebook uses, shares patient communications and other information without their permission. 

The lawsuit lists its plaintiff as John Doe and seeks compensatory and punitive damages. 

Bloomberg reported that close to 33 hospitals use the Facebook tracking tool, which could violate federal health information privacy laws.

According to the lawsuit, there are at least 664 medical providers whose websites have received patient data via Pixel.

Facebook has been in the line of fire about various privacy issues. In February, Facebook was sued by Texas for longstanding and discontinued use of facial-recognition technology that violated that state’s privacy protections for personal biometric data. 

During the same time, Facebook lost a legal battle on data privacy and agreed to pay $90 million to settle the high-profile, long-running data privacy litigation.

https://www.benzinga.com/news/22/06/27778491/meta-sued-for-allegedly-accessing-medical-data

XBiotech: Successful Completion of Phase I portion of Pancreatic Cancer Study

 xBiotech USA, Inc. (NASDAQ: XBIT) announced today it successfully completed the Phase I portion of its 1-BETTER study, a Phase I/II randomized, double-blind, placebo-controlled clinical study to evaluate its anti-cancer drug Natrunix in combination with chemotherapy for treating pancreatic cancer. Enrollment in the Phase II portion is commencing immediately.

Thirty leading cancer centers across the United States are involved in the Phase I/II study. Pancreatic cancer is the 4th leading cause of cancer death in the United States and the incidence has been increasing steadily since 2000. In 2022 about 50,000 people will die from pancreatic cancer in the United States. The Natrunix antibody therapy represents a groundbreaking approach to therapy—with the aim to of reducing treatment related toxicity of chemotherapy while also blocking the tumor-associated signals that spurn growth and spread of tumors.

The key is Natrunix’s ability to specifically target the body’s response to injury. Chemotherapy and tumors both elicit an injury response from the body, and this response may counteract some of the beneficial effects of therapy while at the same time cause substantial morbidity. This injury response plays a crucial role in the growth, spread and morbidity of cancer. Natrunix targets this common pathway activated by cytotoxic therapy and paraneoplastic inflammation. Used in combination with chemotherapy, Natrunix is therefore being assessed for its ability to reduce the side effects of chemotherapy treatment and mediate anti-tumor effects.

The Phase I study enrolled patients in three groups, using escalating dose levels of Natrunix. Subjects received the maximum dosing of Natrunix without a single report of “possibly, probably, or definitely related dose limiting toxicity (DLT)” associated with the investigational agent. Subjects received two 14-day cycles of Natrunix in combination with the chemotherapy drugs Onivyde, 5-fluorouracil and leucovorin. At the discretion of the treating oncologist, after completing the two 14-day cycles, patients were allowed to continue to receive Natrunix if they were deemed to be potentially benefiting from the investigational agent. All patients in the highest dose group have continued to receive Natrunix; at this time a total of 14 additional cycles of therapy have been administered to the Phase I subjects.

https://www.biospace.com/article/releases/xbiotech-announces-successful-completion-of-phase-i-portion-of-pancreatic-cancer-studynovel-natrunix-treatment-shows-promise-in-combination-chemotherapy-for-treatment-of-pancreatic-cancer/

Israel Health Chief: At the start of new COVID-19 wave

Israel is at the start of a new wave of COVID-19 infections, Health Ministry Director-General Nachman Ash said Sunday morning.

The Health Ministry has identified a significant increase in infections, including more than 7,000 on Friday, serious cases and hospitalizations, he told 103 FM.

“I think we can start calling this a new wave,” Ash said, adding that the BA.5 subvariant is similar to the Omicron variant from which it developed in terms of severity and rate of infection.


“In terms of preventative steps, Omicron has changed our approach, and even if this variant is highly contagious, there is no room for restrictions like shutting down or anything like that,” he said.

Israelis walk on the streets of Tel Aviv without wearing protective face masks, as Israel lifts the restrictions on wearing a mask outdoors.  (credit: MIRIAM ALSTER/FLASH90)Israelis walk on the streets of Tel Aviv without wearing protective face masks, as Israel lifts the restrictions on wearing a mask outdoors. (credit: MIRIAM ALSTER/FLASH90)

On Saturday, 4,931 new COVID-19 cases were reported, the Health Ministry said Sunday. There was a 40% positive return rate for about 12,200 PCR and antigen tests that were taken, it said.

There were 158 serious cases, an increase of 125% compared with the previous week, including 42 patients in critical condition, of whom 37 were intubated and two were connected to ECMO machines.

The R-rate currently was at 1.3, a slight drop from earlier last week, when it was 1.51.

Meir Medical Center in Kfar Saba on Sunday said it would be reopening its COVID-19 ward due to an increase in hospitalizations.

Will the Health Ministry be bringing back any COVID-19 restrictions?

At this early stage in the new wave, the Health Ministry does not intend to impose extensive restrictions on large gatherings, as it did in previous waves, Ash said. However, it was considering reimplementing a mask mandate in enclosed public spaces, he said.


https://www.jpost.com/health-and-wellness/coronavirus/article-709802

North Korea abruptly stops importing COVID containment goods from China

 North Korea abruptly stopped importing COVID-19 prevention and control products from China in May, trade data released by Beijing showed, after the country bought face masks and ventilators from its neighbor in previous months.

Daily new cases of fever in North Korea, as reported by its state news agency, KCNA, have been declining since the reclusive country first acknowledged in mid-May that it was fighting a COVID-19 outbreak. However, how many of those cases tested positive for the coronavirus has yet to be revealed.

North Korea did not import any face masks, thermometers, rubber gloves, ventilators or vaccines from China in May, according to data released by Chinese customs on Monday.

That is compared with imports of more than 10.6 million masks, nearly 95,000 thermometers and 1,000 non-invasive ventilators from China in January-April.

South Korea and the United States have offered to provide help, including vaccines, but Pyongyang has not responded.

In this undated photo distributed on Wednesday, Feb. 12, 2020, by the North Korean government, North Korean Premier Kim Jae Ryon, right top, has a meeting at the emergency anti-epidemic headquarter in Pyongyang, North Korea. Independent journalists were not given access to cover the event depicted in this image distributed by the North Korean government. The content of this image is as provided and cannot be independently verified. (Korean Central News Agency/Korea News Service via AP)

In this undated photo distributed on Wednesday, Feb. 12, 2020, by the North Korean government, North Korean Premier Kim Jae Ryon, right top, has a meeting at the emergency anti-epidemic headquarter in Pyongyang, North Korea. Independent journalists were not given access to cover the event depicted in this image distributed by the North Korean government. The content of this image is as provided and cannot be independently verified. (Korean Central News Agency/Korea News Service via AP) ((Korean Central News Agency/Korea News Service via AP))

As Pyongyang has never directly confirmed how many people have tested positive for the virus, the World Health Organization said in June that it assumed the situation was getting worse, not better.

Overall, China's exports to North Korea slumped 85.2% to $14.51 million in May from $98.1 million in April.

A worker repairs the ground at a container port in Qingdao in eastern China's Shandong province Wednesday, June 8, 2016. China's exports and imports contracted again in May in a sign of weak global and domestic demand. (Chinatopix Via AP) 

A worker repairs the ground at a container port in Qingdao in eastern China's Shandong province Wednesday, June 8, 2016. China's exports and imports contracted again in May in a sign of weak global and domestic demand. (Chinatopix Via AP)  (The Associated Press)

The top export items were soybeans, granulated sugar, soybean meal and wheat flour.

North Korea bought $2.97 million worth of soybeans, $2.64 million of granulated sugar, $1.49 million of soybean meal and $846,598 of wheat flour in May, the Chinese customs data showed.

BEIJING, CHINA - DECEMBER 20: Chinese Foreign Ministry spokesman Zhao Lijian attends a news conference on December 20, 2021 in Beijing, China. 

BEIJING, CHINA - DECEMBER 20: Chinese Foreign Ministry spokesman Zhao Lijian attends a news conference on December 20, 2021 in Beijing, China.  ((Photo by VCG/VCG via Getty Images))

Chinese foreign ministry confirmed on April 29 that China had suspended cross-border freight train services with North Korea following consultations due to COVID-19 infections in its border city of Dandong.

https://www.foxnews.com/world/north-korea-stops-importing-covid-containment-goods-china