Medical research ‘just starting to scratch the surface’ on cytokine storm syndrome

Messenger: South City Hospital bucks trend, won’t require COVID-19 vaccines for health care workers | Tony Messenger

Over the next month, nurses and other health care professionals who for one reason or another don’t want to get vaccinated will be fired from their jobs at Mercy, BJC and other local hospitals. More than 20 national hospital chains have adopted a similar philosophy. South City, on the other hand, is following the lead of some rural hospitals in Missouri, in areas with low-vaccination rates, where they are actually using their lack of a mandate as a recruitment tool.

The result is that the population South City Hospital serves — generally high in poverty and in an area of the city where vaccination rates have been low, particularly among African Americans — will be entering a hospital where the health care workers may or may not be vaccinated.

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At least some employees at South City Hospital, who spoke with me on condition of anonymity, are concerned about this policy. But not all of them. One woman who works there, who said she is vaccinated, said she agrees with the philosophy and hopes the hospital uses it to recruit employees.

“It’s a personal choice,” she says.

The patients who come to South City Hospital, however, often have no choice in where they seek health care. Many of them are uninsured, or they come to the emergency room because of addiction issues or other mental health issues. This population in St. Louis will remain at a higher risk of contracting COVID-19 because one hospital won’t follow the lead of the others.

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What Medical Researcher Training Can Learn From the ‘Yellow Berets’

Gottesman worked with Martin Gellert, who had at that point just discovered the enzyme DNA ligase, the central enzyme for DNA replication and repair. About one year into the program, Gellert took a sabbatical, which gave Gottesman independence to pursue his own research ideas. He also took over teaching a part of Gellert’s course at the NIH on how DNA is transcribed and translated into proteins. “Not only did I have this incredible opportunity to be an independent researcher, but I suddenly had a fairly major teaching responsibility. It was just a wonderful experience for me,” Gottesman says.

After the program, Gottesman returned to Harvard, where he’d done his undergraduate and medical studies, finished his residency, and started as an assistant professor. But soon, he recalls, he “heard the siren call of NIH” and returned to start his own lab at the National Cancer Institute.

After the draft ended, applications to the ATP declined. The program no longer exists, although a similar one—the Medical Research Scholars Program—supports medical, dental, and veterinary students who do research on the NIH campus. The agency is still working to “capture that lightning in a bottle that was this program,” Gottesman says.

Today, a few universities offer similarly intensive programs. For instance, Hall’s three-year program supports about 20 junior investigators in developing independent research careers. It’s funded via NIH KL2 awards, which are given to new clinicians to do research. “In many ways,” she writes, “the KL2 programs provide similar mentored research training as that in the NIH program, at institutions nationwide.”

The Meyerhoff Scholars Program, which is in its 33rd year, also has many of the elements of the ATP, although its emphasis is on biomedical research as a whole, rather than translational or clinical research. The program also includes a relatively large, strongly-bonded 50- to 60-person cohort, and intensive exposure to research at the pre-doctoral level. According to Sto. Domingo, its scholars are about five times more likely to earn a scientific PhD than students who were accepted to the program but declined to attend. It is now being used as a model for similar programs at the University of North Carolina at Chapel Hill and Penn State. Sto. Domingo says new programs at UC Berkeley, UC San Diego, and Howard University are also being established based on its model.

Still, medical research careers have changed since the 1960s and 70s. Today, a major obstacle is the debt burden of med school, which is often in the hundreds of thousands of dollars. Debt can incentivize young doctors to choose lucrative specialties so they can repay their loans. As a result, there is a shortage of investigators who are able to combine clinical expertise with research inquiry, writes Hall. In the US, she writes, each year more than 20,000 people graduate with an MD, but only about 600 earn both medical and research doctorates.

Another challenge, writes Hall, is that it’s getting more difficult to manage a dual career doing research and taking care of patients, because it is harder to obtain research funding to support a laboratory, and there are more opportunities to focus on clinical care.

Because the research ecosystem is always changing, Azoulay envisions the Yellow Berets study as a starting point for further research: rigorous studies that would compare training interventions in terms of timing, cohort size, and other factors. “What we’d like people to take away is not that you should copy what the NIH was doing in the early 1970s,” Azoulay says. Rather, this analysis should inspire new experiments. ​”We want randomized controlled trials to come to the world of scientific training and scientific funding,” he continues. “If we have a bee in our bonnet, it’s that one.”

Disclosure: Viviane Callier has a contract statistician role that supports some data analysis projects at the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health.

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GIANT Health Announces Launch of New Medical Research Programme

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Colorado nurse transforms Covid vaccine vials into a work of art to show appreciation for health care workers

Laura Weiss told CNN she was a retired nurse when Boulder County Public Health asked for help administering vaccines in February.

“I had noticed all these hundreds and hundreds of empty vaccine vials that were otherwise going to be wasted, and I thought they were just really beautiful and wanted to do something significant and meaningful with them,” Weiss said.

Weiss got permission to use the glass Moderna vaccine vials and created a beautiful chandelier.

“I realized I wanted to do something with light because I just felt like it’s been such a dark and challenging year for so many people that like the idea of bringing a light to this,” she said.

“I think that light can represent hope and clarity and it also has the potential to actually expand the bigger view and verify perspective.”

The actual idea of making a chandelier came from an eBay purchase. She found the empty frame online and thought it would be a great vessel for her project.

“From a distance…the chandelier just looks like a regular chandelier, but as you get up closer to it, it becomes actually something very different and it changes your perspective,” she said.

“It reminds me that we can see something one way and as you get closer or look at it differently, our assumptions can actually be very incorrect.”

The art piece doesn’t have a permanent home yet, but Weiss said that wherever it goes, she wants everyone who sees it to understand her intention to honor healthcare workers who put their health and lives on the line during the pandemic.

“There’s too many people and professions to mention, but especially these nurses who I just witnessed work tirelessly, hours and hours and hours, and days and days and days, without a day off, who just have so much passion and skill, and care and kindness,” she said.

“How do you say thank you to someone who is just doing so much for others? It’s so inspiring.”

However, Weiss is now giving back and inspiring others.

“This light of appreciation art piece is really important because I think we’re all seeing this sense of unity at this point as we see the Delta variant surge,” Angela Simental, the communications and marketing manager for Boulder Public Health, told CNN.

“We’re really happy to have this kind of light in art to remind us that we can protect ourselves and others by getting vaccinated by being kind to each other and by honoring the efforts of everybody involved in this.”

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University of Hawaii medical school to study if hula can help to prevent, delay dementia

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After teaching thousands of students over the past 45 years, kumu hula Mapu­ana de Silva of Halau Mohala ‘Ilima said she believes anyone can benefit from hula in some way. At 72, she said she’s seen how hula has helped to improve her own health and the well-being of her haumana (students).

“Hula is one of the best ways to stay in good health, not necessarily only physically, but mentally, emotionally and spiritually, and especially for Native Hawaiians because this is our culture,” she said. “Anyone who wants to can dance hula. Once you find the right teacher, you’ll find that hula unlocks so many doors to the world.”

De Silva and other kumu hula are partnering with the University of Hawaii’s John A. Burns School of Medicine to study if hula, coupled with other lifestyle interventions, can help improve vascular health and maintain or improve cognitive function for Native Hawaiian and Pacific Islander kupuna at risk for Alzheimer’s disease and dementia. The study builds on previous research that showed hula can help improve blood pressure and reduce the risk of cardiovascular disease and other chronic conditions among Hawaiians, and also aims to address the gap in public health access and research of indigenous communities.

The project is part of a larger initiative nationwide to address health disparities associated with Alzheimer’s disease and dementia among Native Hawaiians, Pacific Islanders, American Indians and Alaska Natives. Led by Washington State University, the project was awarded a $15 million grant from the National Institute on Aging, according to JABSOM.

Researchers are collaborating with 11 tribes, six academic and research institutions, seven Indian organizations and five Native Hawaiian and Pacific Islander community groups to study and better understand Alzheimer’s disease and dementia among indigenous populations.

Joseph Keawe‘aimoku Kaholokula, chairman of Native Hawaiian health at JABSOM and the project’s lead in Hawaii, said the specifics of the program are still being developed but recruitment of more than 200 participants is expected next spring. To qualify for the study, participants must be at least 50 years old, Native Hawaiian or Pacific Islander, have vascular risk factors such as high blood pressure, high cholesterol, obesity and diabetes, and show early signs of memory loss.

Once selected, participants will take hula classes twice a week taught by kumu hula on Hawaii island, Maui and Oahu for three months, and then will receive a mixture of hula and lifestyle intervention sessions focusing on healthful eating, stress management and exercise.

Researchers will monitor participants’ blood pressure, weight, blood sugar levels and cholesterol at different points during the one-year study.

The goal, Kaholokula said, is to get participants into the study early enough to help delay or even prevent them from developing full dementia.

“We’re hoping hula itself will be a cognitive exercise because they have to learn the (Hawaiian) language, memorize songs and chants, and do complex movements,” he said. “Social and cognitive engagement has also been shown to actually help people in reducing their risks for dementia in the future.”

Kaholokula and de Silva agree the research is particularly important for indigenous communities, who they say are over-represented when it comes to these chronic conditions but underrepresented in research and data. Kaholokula said he can recall only a few Alzheimer’s-related studies that have included Native Hawaiians and Pacific Islanders.

Nationally, more than 6 million people are living with Alzheimer’s disease, according to the Alzheimer’s Association. Dementia, a broader term used for a decline in cognitive function that interferes with daily life, and Alzheimer’s disease, the most common cause of dementia, are among the leading causes of death in seniors, even higher than breast and prostate cancer combined.

In Hawaii, 29,000 kupuna aged 65 years and older are living with Alzheimer’s disease, which is the fifth- leading cause of death in the state. That number is projected to jump to 35,000 in 2025.

Research shows NHPIs are more likely than white, Asian and African American populations to develop early onset Alzheimer’s disease and dementia in the U.S. But there is no data available for NHPIs in Hawaii. In 2019, the Alzheimer’s Disease Research Centers, a major source of data on dementia, included just 29 NHPIs out of its more than 38,000 study participants.

But data does show that NHPIs have a higher prevalence of high blood pressure, obesity and diabetes, which are risk factors that increase the likelihood of developing dementia, than any other ethnic group.

De Silva and Kaholokula agree that using culturally based practices when addressing health can be key to providing participants with an activity that resonates with them and to which they feel connected.

During their previous study on how hula can help to improve blood pressure and reduce the risk of cardiovascular disease among Hawaiians, they had an 80% retention of participants over one year, which Kaho­lokula said is uncommon for clinical trials. It was also one of the first studies to use a cultural practice to address cardiovascular disease in an indigenous population, he said.

They also pointed out that some of the participants joined a halau and have continued dancing even after the study ended.

De Silva said she hopes the benefits of hula will extend beyond the study’s parameters.

“We want to prove that culture, as it exists, already contains the elements needed to stay healthy. That is first and foremost in every study we’ve done,” she said. “We’re not trying to make the people who come into our studies hula dancers. We’re hoping that hula, at the very least, will be the catalyst to motivate them to take charge of their health.”

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Jayna Omaye covers ethnic and cultural affairs and is a corps member of Report for America, a national serv­ice organization that places journalists in local newsrooms to report on under­covered issues and communities.

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Centivax and US Naval Medical Research Center to begin Phase I clinical trial of antibody therapeutics

Centivax Inc. announced today that it has entered into a strategic partnership with the U.S. Naval Medical Research Center (NMRC) for Phase I clinical development of Centi-B9, Centivax’s SARS-CoV-2 broad-spectrum injectable antibody therapeutic and prophylactic.

Centi-B9 has been engineered to broadly neutralize the mutated emerging coronavirus variants, with demonstrated broad-spectrum reactivity against 99.5% of all coronavirus variants in the U.S.A, and over 98% of coronavirus variants globally, including critical mutations found in the UK B.1.1.7, South African B.1.351, Brazilian P.1, New York B.1.526 and California B.1.429 strains.

Rather than requiring an IV infusion, Centi-B9 has been bioengineered for high stability, low viscosity high concentration (250mg/ml) delivery, enabling a prophylactic or therapeutic dose of Centi-B9 to be delivered in a non-hospital setting through a single injection. Centi-B9 has been further engineered for enhanced safety and enhanced half-life, using Xencor Xtend technology.

Broad-spectrum. High-concentration. Enhanced safety. The Centi-B9 biosuperior represents the first clinical example from the Centivax portfolio of next generation antibody therapeutics bespoke engineered to specific needs of patient populations and the diseases that they confront. With discovery research supported by Medical Technology Enterprise Consortium, and now clinical development supported by our remarkable collaboration with the Naval Medical Research Center, this biotech-government partnership is proud to advance this molecule into clinical development and closer to the patients and doctors that need a better medicine to end the pandemic.”

Dr Jacob Glanville, CEO, Centivax

In the strategic partnership Centivax and NMRC will each contribute a Principal Investigator to the clinical study, and NMRC will host the Phase I clinical trial site for intramuscular and subcutaneous delivery of Centi-B9, as well as providing support for protocol development and medical oversight. The Henry Jackson Foundation is providing $4.2M US in non-dilutive funding support for the trial. The Phase I trial will demonstrate safety and pharmacokinetics of the Centivax monoclonal in healthy volunteers and is planned to begin in July of this year. These Phase I studies will enable a Phase II/III adaptive trial to begin later this year. The Phase II/III trial will study efficacy in several patient populations, including hospitalized COVID-19 patients, pre-hospitalized COVID-19 cases, post-exposure prophylaxis and pre-exposure prophylaxis. Given the unmet need for a broad-spectrum injectable, Centivax will seek Emergency Use Authorization during interim analysis.

While vaccines appear to be very effective against some strains of the virus, they known to provide reduced protection against many of the emerging variant strains, with further reductions in protection anticipated to continue as the virus continues to mutate. This is particularly important to the Navy, since individuals on long deployments may come into contact with these variants at international ports of calls.

“Our highly concentrated, thermostable, neutralizing antibody fits the needs of the Navy, and DOD in general, in that it can be administered intramuscularly to warfighters in cramped quarters or austere environments to boost and extend protection already afforded by vaccination,” said Dr. David Gangemi, Ph.D., Chief Government Relations Officer for Centivax. “Our antibody is highly effective against over 98% of the currently circulating variants and is a good fit for use in prolonged deployments when prophylaxis and/or post-exposure treatment is needed.”

Centi-B9 can be used either prophylactically to protect against COVID-19, or as an adjunct to vaccines to provide complete protection, or as an early interventional therapy for those who chose not to be vaccinated and subsequently became infected with SARS-CoV-2. Centi-B9 is a highly stable product that can be stored for extended periods in standard refrigeration conditions and can be administered ship-board prophylactically to prevent the risk of transmission.

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