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A doctor’s journey through constraints and creativity in the ER

For Immediate Release Credit: The MIT Press, 2022. For Immediate Release “Tornado of Life is a tour de force. It features patient narratives, sketches…

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For Immediate Release

Credit: The MIT Press, 2022.

For Immediate Release

Tornado of Life is a tour de force. It features patient narratives, sketches of the ER, self-portraits of [Baruch’s] development as a provider throughout [his] career, and [his] reflective and analytical essays on the multidirectional relationships between narrative and healthcare. It’s a many-faceted collection.”
Synapsis Journal

 

“Through stories that are often tender, sometimes chaotic, and always revealing, Jay Baruch beautifully conveys the messy art of doctoring. Read Tornado of Life to understand the emergency room in all its glory—warts and all.”
Sandeep Jauhar, author of Intern: A Doctor’s Initiation

 

To be an emergency room doctor is to be a professional listener to stories. Each patient presents a story; finding the heart of that story is the doctor’s most critical task. More technology, more tests, and more data won’t work if doctors get the story wrong. When caring for others can feel like venturing into unchartered territory without a map, empathy, creativity, imagination, and thinking like a writer become the cornerstones of clinical care. In Tornado of Life: A Doctor’s Journey Through Constraints and Creativity in the ER (The MIT Press, on sale 8/30/2022), ER physician Jay Baruch shares these struggles in a series of short, powerful, and affecting essays that invite the reader into stories rich with complexity and messiness.

Patients come to the ER with lives troubled by scales of misfortune that have little to do with disease or injury. ER doctors must be problem-finders before they are problem-solvers. Cheryl, for example, whose story is a chaos narrative of “and this happened, and then that happened, and then, and then and then and then,” tells Baruch she is “stuck in a tornado of life.” What will help her, and what will help Mr. K., who seems like a textbook case of post-combat PTSD but turns out not to be? Baruch describes, among other things, the emergency of loneliness (invoking Chekhov, another doctor-writer); his own (frightening) experience as a patient; the patient who demanded a hug; and emergency medicine during COVID-19. These stories often end without closure or solutions. The patients are discharged into the world. But if they’re lucky, the doctor has listened to their stories as well as treated them.

Additional Endorsements:

“A book that, with huge empathy and compassion, builds a bridge between doctor and patient, writer and reader. Engaging and thoughtful.”
Sinéad Gleeson, author of Constellations

“Among the vast literature of doctors writing about their profession, Dr. Jay Baruch is a unique talent, a spellbinding storyteller and an expert and experienced diagnostician. With literary references and poetic flare, Tornado of Life reveals the whirlwind of emotions gusting through emergency rooms. Rarely does a physician admit his own vulnerabilities and uncertainties in a way that illuminates the true art of his healing.”
Randi Hutter Epstein, Writer in Residence Yale School of Medicine, and author of Aroused: The History of Hormones and How They Control Just About Everything

About the Author:

Jay Baruch, a practicing emergency room physician, is Professor of Emergency Medicine at Alpert Medical School of Brown University and the author of two award-winning short fiction collections, What’s Left Out and Fourteen Stories: Doctors, Patients, and Other Strangers.

 

A Talk with Dr. Jay Baruch, Author of  Tornado of Life: A Doctor’s Journey through Constraints and Creativity in the ER

How did you arrive at the title for your book—what does it mean to you?

These were the words from a hard-luck ER patient who I describe in the book. Her troubles had troubles. At first, she wouldn’t talk to me. I sat with her, silent. Finally, she said, “I’m stuck in the tornado of life.” That metaphor, spoken as an aside, was so raw and true. So often patients speak poetry without realizing it. But it also resonated more broadly with my experience on the frontlines, people reaching for help for problems that have roots in forces—physical, medical, psychological, familial, economic, and social—that are beyond their control. At various times, and to different degrees, we all are tested by the tornado of life.

Your book is subtitled “A Doctor’s Tales of Constraints and Creativity in the ER.” What are some of the biggest constraints?

There are many: Obvious examples include factors such as time, interruptions, being forced to make decisions based on incomplete information, hospital challenges like boarding admitted patients to the hospital in the ER, healthcare system obstacles, resource limitations, and the expectations that the ER will be the safety net for problems, not just medical problems, that the system and communities can’t or don’t want to handle.

But there are other less explicit constraints, like emotional limits, limits in compassion, working with patient expectations/demands that may not be reasonable, trying to uphold a social justice mission in an unjust system.

There is a moral force at the heart of medicine, especially in emergency medicine when the doors are open 24/7. This may be where the constraints are felt most acutely, because I feel the Turduckin, that weird Thanksgiving Russian doll of birds, is an apt metaphor for our healthcare system, with its      moral center stuffed inside profit-driven industries stuffed into a political agenda. Emergency physicians and many of my colleagues in primary care, etc., practice in this dark, tight, pressured space. 

Can you give us examples of creativity being used in the ER to eliminate a constraint?

I believe, like so many others, that we’re naturally creative, only the reductionist focus in medicine on finding an answer and being right often gets in the way of being more open and curious. Thinking about patients as cases to be solved rather than people with problems, needs, and fears to be explored is an unacknowledged constraint with real consequences. What we decide to pay attention to is a choice. Why are we making those choices? Are we choosing problems with ready solutions? Have our brains jumped to an answer and are now only paying attention to details that support that conclusion, at the exclusion of vital information which belongs to the patient’s real story? I found I did a better job ensuring the story I’m hearing resembles the story the patient is telling by thinking more like a creative writer at the bedside and moving into open spaces. This can be hard. Our brains are hardwired to create stories, even out of incomplete, scattered information. It starts with constantly interrogating our thinking process. This doesn’t mean I’m perfect. After thirty years, I’m still a work in progress, but given the time constraints and other pressures, I derive comfort having these tools in my toolbelt.

I feel creativity and story skills are the most cost-effective and disruptive technology in medical care. The process of connecting with patients, working with uncertainty, making medical decisions, and reducing medical errors all require sophisticated story skills.

Years ago, an esteemed professor of medicine offered this remark after I gave a talk at his medical school: “You’re an ER doc. You don’t have time for story.” And he’s right. There are many constraints and they’re not going away. But these constraints won’t stop people from bringing their stories to the ER. And these pressures are no longer specific to the ER, as providers in other medical fields and across healthcare are forced to spend less time with more patients.

What are we not teaching in medical school that we should be teaching?

I believe I received a very good medical education and wonderful training in emergency medicine. But I wasn’t trained in what I soon learned was a source of deep distress for me:  working with uncertainty. Medical education should be built around understanding stories, critical thinking, and working with uncertainty. We need skilled evidence-using clinicians who think like artists, who are skilled at problem finding and problem solving, who know how to read silences. If the pandemic has taught us anything, it’s the need for medicine to be more adaptable to complexity.    

Medicine often leans on research studies and big data to guide clinical care–and I’m grateful for this knowledge–but sometimes data is the wrong tool for understanding the messiness of individual lives, the tiny, complicated moments that are ripe with uncertainty, contradictions, and doubt that challenge both patients and the clinicians who care for them. It’s important to know your stuff, but not-knowing is equally important. There are times when knowing the answer is less important than knowing how to ask the right questions. That isn’t always emphasized in medical training.

Your book is peppered with the stories of patients. Clearly many of them have stuck with you over the years. Is there one who you carry with you, in particular?

This book captures many that stuck with me. These aren’t of the “craziest thing you ever saw” variety, with blood, mayhem and high drama, which is only a small part of emergency medicine. More often, I’m faced with lives stressed by misbehaving bodies, a hornet’s nest of social issues, and feelings of vulnerability, fear, and a loss of control, and I must tend to their less obvious wounds. These quieter moments are often the hardest parts of my practice. In fact, I had trouble making sense of them myself and found writing and rewriting was the only authentic way to come to an understanding. Can I name one patient? No. There are many experiences and patients that I carry around with me that I never wrote about, powerful people and stories that I cherish.

In your book, you tell the story of a young, well-dressed woman who arrived at your emergency department in the middle of the night complaining of chest pain. You were unable to figure out what was wrong with her until she took mercy on you and clued you in. Can you share that story with us?

She stood out because she was so well dressed and put together compared with everyone else that Saturday night in this city hospital, and that includes the staff. She had various complaints, including chest pain and shortness of breath. It was very early in my emergency medicine career. Instead of being alert to the gaps in her story and probing what she wasn’t saying, I embarked on a workup that focused on possible medical causes for her complaints—including a heart attack and a blood clot in her lung. I missed what she ultimately revealed to me after I ran various tests throughout the night—she was a victim of interpersonal violence by her husband.

What can doctors learn from their patients?

Many things. Patients, like all of us, are rich with wonderful contradictions. They can’t be summed up easily and our biases are often proven wrong. Patients are often the experts on their bodies and their experiences. Often seemingly minor issues are huge sources of suffering for patients. Patients aren’t all the same. Even the patient suffering from a heart attack impacting the same part of the heart will experience it differently. Patients value honesty, and they know when they’re being read lines from a script. They’re more comfortable with uncertainty. What they want from doctors isn’t always an answer, but the attention of another human.

What did you learn from your own experience as a heart patient?

  • ER stretchers are uncomfortable. I tell patients if you didn’t come in with a back problem there’s a good chance you’ll leave with one.
  • ER curtains don’t prevent sound. Lying there with nothing to do, I can hear everything.
  • I’m very aware of “waiting” time.
  • Symptoms won’t go away if you just ignore them.
  • Doctors are terrible at being sick and the culture of medicine expects doctors to work when we’d yell at our patients for doing the same thing. I was running around the ER in heart failure and atrial fibrillation. There were times I was the sickest patient in the ER and I was the doctor.
  • After promising my wife that I’d cut down on my hours if I recovered, I went back to my old work habits and became sicker.
  • As a doctor who was sick, I’d get comments about how being a patient would make me a more caring doctor. In some ways, it did. In some ways, it didn’t. And it wasn’t a cozy narrative. Most of all, I simply wanted permission to be sick.
  • I was surprised by what I thought I needed in a cardiac surgeon.
  • Nurses, physical therapists, aides, etc. can’t be paid enough.
  • It’s the little gestures that patients often remember the most.
  • Always say thank you.

What qualities do you think the best emergency department doctors possess?

  • Tolerance
  • Curiosity    
  • Vulnerability
  • Acceptance of imperfection
  • Emotional intelligence
  • Comfort with uncertainty    
  • Diligence
  • A touch of the outlaw
  • An appreciation for the absurd
  • A good sense of humor
  • Genuine affection for people.

In chapter 14, you say “An argument can be made that a hug deserves recognition as a bona fide medical treatment.” Can you tell us the story of Fawn—and what it taught you?

I first wrote about Fawn because she asked me for a hug, and I came to question why she asked for it and why I hugged her. She was homeless, with substance use issues and mental health problems. She asked for a hug, and I couldn’t say no. As a physical display, it appears straightforward. But it’s as primal, emotionally rich, and perilous as any poem. In the process of writing about this experience, I found myself considering why a hug is so powerful and treacherous. I reexamined why it might have been the most important part of my care for her and why a hug is risky in today’s times. During the first wave of covid when we were gowned and masked and kept a distance from patients when possible, I discovered patients craved human touch.

What are some of the influences that contribute to burnout in medicine, and is there anything we can do about them?

Emergency medicine clinicians, along with other frontline specialists, smolder with precarious rates of depression and burnout. Burnout is a syndrome marked by depersonalization, emotional exhaustion, and a low sense of personal accomplishment. I respect this thing called burnout while remaining skeptical of any categorizing scheme that tries to squeeze a heterogeneous set of factors into one package.

When physicians suffer, patients may suffer, too. When my emotional reserve drops, it means I have a limited supply of what my patients deserve: compassion, patience, and a willingness to follow unwinding stories.

Many influences contribute to burnout in medicine. They include lack of control over the work environment, a disparity between personal values and those of the system, more time spent with electronic health records than with patients, and a sense of not making a difference. The medical-legal climate adds heat to this pot. There are stressors specific to emergency medicine that place its practitioners at further risk for burnout, including shift work and the constant exposure to patients suffering from extreme physical and emotional trauma.

It’s no secret that systemic change is ultimately the solution to this thing we’ll call burnout. In the meantime, I feel we must have more honest and authentic dialogue around this topic, not as a problem to be solved but as a mystery to be explored.

Also, I’ve experienced this thing called burnout again and again over my career. In my experience, burnout often impacts physicians who care the most. But burnout, I feel, isn’t a snuffed flame. The key is learning how to burn back in. Writing has been critical for me in burning back in.

What about caregiver burnout?

In my book I also discuss a case of caregiver burnout, which results when caregivers don’t get the help they need, try to handle too much, or take on things they aren’t capable of. Even when undertaken from a wellspring of generosity and love, caregiving can produce physical, emotional, and psychological exhaustion. When caregivers do carve out time for themselves, they are inclined to feel guilty about it, resulting in a paradoxical worsening of their burnout. And yet, we don’t expend much energy probing the caregiver’s experience, discussing the burdens of such work, and recognizing the challenges they face.

In chapter 16, you talk about “compassion confusion.” What is it, and what are some of the factors that cause it?

Compassion fatigue in healthcare workers results from constant contact with patients and their traumatic and stressful experiences. It’s marked by symptoms that include apathy, depression, mistakes in clinical judgment, problems with sleep, and feelings of helplessness and anger. There’s also compassion satisfaction, positive emotions that emerge from the act of caregiving. In the book, I describe working through a situation where my compassion didn’t grade onto this scale. It was neither exhausted nor a source of meaning. I suffered from compassion confusion. I describe how we don’t often talk about compassion as a justice problem. How do we allocate compassion to everyone who needs and deserves it fairly and equitably, especially when the choices lead to zero-sum gain—a win for one person must come as a loss for others? The cause, often, emerges out of system problems that force us into situations that stress our compassion to a point where our moral compass can’t find a true north.

You describe “the crisis of emergency department crowding” in detail in your book. Can you give us an overview of its risks and the difficult decisions that have to be made because of it?

Crowding or ER boarding is when the emergency department’s rooms are filled with admitted patients waiting for a room in the backed-up hospital wards upstairs.

Crowding and prolonged waits in the ER are more than an inconvenience; they’re linked to grave medical consequences, including higher inpatient mortality, longer length of stay in the hospital, increased medical errors, more harmful cardiac outcomes, and delayed treatment for pain.

ER crowding is a national problem described as a sign of an unhealthy hospital system. The ongoing pandemic amplified the crowding problem for many of us, often to excessive degrees, owing to illness severity, longer inpatient stays for COVID-19 patients, and staffing shortages.

The crisis of emergency department crowding turns each possible bed belonging to someone who isn’t admitted to the hospital into a scarce resource. When there are only a handful of functional beds and there are 30 or 60 patients in the waiting room, it requires making tough decisions. In the book, I discussed the dilemma of whether to discharge a homeless man with alcohol problems, someone who sometimes comes to the ER intoxicated twice in one day, into a freezing winter night.

Pre-Covid, what was the hardest thing about being an emergency department doctor?

Trying to meet the expectations of patients with multiple needs: medical, social, mental health, substance use, and often feeling like you weren’t making a difference. Being expected to be fast, compassionate, accurate, document thoroughly in the medical record and doing it for multiple patients simultaneously. The human brain wasn’t designed to do the cognitive tasks we take for granted.

Our concept of normal is very abnormal. We are expected to care for patients who physically and/or verbally assault us.  We are exposed to trauma, death, and injustice every day and we’re expected to move on, a perilous coping strategy. We are ambassadors to nightmares for families who receive devastating news from us about loved ones who were living their normal life only hours before. The opioid crisis has turned the treatment of pain into a moral cage-fight filled with subjectivity and grave consequences regardless of what you do. There are other challenges as well: facing the complexity of end-of-life decisions, responding to loneliness as a medical emergency, and struggling to forgive yourself when unexpected outcomes happen to patients.

What’s it like being an emergency department doctor during Covid?

Everything above still applies, only amplified.

It’s changed with each wave. The first wave was difficult and meaningful. There was an all hands on deck mentality. The ER staff came together. For many of us, this crisis was a reminder of why we went into medicine, even if it was frightening. We didn’t understand the virus. We feared bringing it home to our families. There wasn’t enough PPE. We had to get used to wearing an n95 mask, which wasn’t meant to be worn for 9-10 hours at a time, with a surgical mask on top of that and then a face shield. Communicating with patients and each other was hard. It felt like every shift we were told something new, often based on the lack of PPE.

The next wave was a bit of déjà vu. Not again. We dreaded going back into Covid units in the ER and having to wear layers of gowns and masks once again. The fact that people weren’t wearing masks or socially distancing made it hard on many of us who made sacrifices at work and at home. It was also hard because ER volumes were returning, and patients were much sicker because of all the disruptions in care during the first wave. In addition, we were seeing spikes in mental health problems and substance use disorder.

The next wave, which was delta in the northeast, was hard because we were drained. We had a vaccine and not enough people were getting vaccinated, wearing masks, etc. People were sicker in general. Substance use and mental health problems were overwhelming. ER crowding was impacting care.

The latest wave: omicron, toast, and trust. New highly transmissible variant, the staff are toast, and we’re also fighting against a pandemic of mistrust.

Do you have a message for people who haven’t gotten vaccinated or boostered?

Please get vaccinated. It works. I realize people choose to go unvaccinated for many reasons, often a lack of trust in healthcare providers, the healthcare system, and in experts at the heart of the issue. The internet is filled with different voices making different claims. Distinguishing valid information from misinformation can be hard for people. We need more engagement and dialogue, not blame and accusations.

No single narrative can hold the weight of this moment and the decisions people must make when faced with high-stakes uncertainty and different frames of belief. If I’ve learned anything in my three decades as a professional listener and teller of stories, in the ER and on the page, it is the importance of humility.

We humans are beautifully flawed creatures with inexplicable needs and impulses that often run counter to our best interests. It’s not always easy to understand another human, but it’s possible and necessary. We’re not going to be perfect, but making the effort matters, especially now, because our only way out of this crisis is together.

How has writing made you a better doctor?

It’s hard to find time to write, but I’ve discovered over the years that I’m a better doctor when I’m writing. I’m wired into the world around me and to others more acutely when I’m writing. I feel like I’m most understanding, tolerant, calm, and insightful in the ER after a good writing day at home. I become irritable when I’m not writing, a lesser version of myself. This has nothing to do with producing or publishing, but the act of staying in touch with that caring, creative side. Working through ideas and with language, playing with voice and points of view, processing emotions, being constantly reminded of how hard it can be to take what’s right there in my head and put it into words—keeps these vital muscles stretched and engaged. They’re muscles that are critical for being a doctor on the frontlines.    

Your book isn’t structured like other books written by physicians. Why is that?

I wanted the form of the book to reflect the content. I aspired to take the reader into particular experiences, but also show what it feels like to move from story to story as we do in the ER, from one emotional place to another, to feel the accumulation of uncertainty and messiness. What’s the right thing to do when the “right thing” is the very thing in question?

Sometimes, there’s no map for caring for others. It can feel like unchartered territory. These moments can be uncomfortable and I wanted to be honest about that discomfort and try to share that struggle. In many of these tales I share some missteps and why I acted the way I did. I’ve always been fascinated by the call for physicians to be more human, but humans are less than perfect creatures and yet physicians are often not allowed to be imperfect.

You wrote this book during the pandemic. What was that like?

Working in the ER through each wave of the pandemic, watching the changes in medicine and our society, would have been more difficult if not for this book. It kept me anchored and focused on something not pandemic related, but it also forced me to remain in constant touch with my feelings and values, to evaluate my relationship with medicine and the meaning of emergency medicine.  It was a source of hope. Of course, the pandemic also provided a different lens for examining certain situations in the book, like giving bad news and the boundaries of physical touch, so the book went to places in response to the challenges in the pandemic.

I was fascinated that many writers wrote how they couldn’t write during the first phases of the pandemic for many reasons. Meanwhile, I found it absolutely necessary. 

 

 

Tornado of Life by Dr. Jay Baruch

$27. 95 T

ISBN: 9780262046978

320 pp. | 5.25 in x 8 in

Publication Date: August 30th, 2022

                                                                                                          


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Spread & Containment

TJ Maxx and Marshalls follow Costco and Target on upcoming closures

Many of these stores have information customers need to know.

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U.S. consumers have come to increasingly rely on the near ubiquity of convenience stores and big-box retailers. 

Many of us depend on these stores being open practically all day, every day, even during some of the biggest holidays. After all, Black Friday beckons retail stores to open just hours after a Thanksgiving Day dinner in hopes of attracting huge crowds of shoppers in search of early holiday sales. 

Related: Walmart announces more store closures for 2024

And it's largely true that before the covid pandemic most of our favorite stores were open all the time. Practically nothing — from inclement weather to bad news to holidays — could shut down a major operation like Walmart  (WMT)  or Target  (TGT)

Then the pandemic hit, and it turned everything we thought we knew about retail operations upside down. 

Everything from grocery stores to shopping malls shut down in an effort to contain potential spread. And when they finally reopened to the public, different stores took different precautionary measures. Some monitored how many shoppers were inside at once, while others implemented foot-traffic rules dictating where one could enter and exit an aisle. And almost every one of them mandated wearing masks at one point or another. 

Though these safety measures seem like a distant memory, one relic from the early 2020s remains firmly a part of our new American retail life. 

A woman in a face mask shopping in the HomeGoods kitchen aisle.

Jeff Greenberg/Getty Images

Store closures announced for spring 2024

Many retailers have learned to adapt after a volatile start to this third decade, and in many ways this requires serving customers better and treating employees better to retain a workforce. 

In some cases, the changes also reflect a change in shopping behavior, as more customers order online and leave more breathing room for brick-and-mortar operations. This also means more time for employees. 

Thanks to this, big retailers have recently changed how they operate, especially during holiday hours, with Walmart recently saying it would close during Thanksgiving to give employees more time to spend with loved ones.

"I am delighted to share that once again, we'll be closing our doors for Thanksgiving this year," Walmart U.S. CEO John Furner told associates in a video posted to Twitter in November. "Thanksgiving is such a special day during a very busy season. We want you to spend that day at home with family and loved ones." 

Other retailers have now followed suit, with Costco  (COST) , Aldi, and Target all saying they would close their doors for 24 hours on Easter Sunday, March 31. 

Now, the stores that operate under TJX Cos.  (TJX)  will also shut down during the holiday, including HomeGoods, TJ Maxx and Marshalls

Though it closed on Thanksgiving, Walmart says it will remain open for shoppers on Easter. 

Here's a list of stores that are closing for Easter 2024: 

  • Target
  • Costco
  • Aldi
  • TJ Maxx
  • Marshalls
  • HomeGoods
  • Publix
  • Macy's
  • Best Buy
  • Apple
  • ACE Hardware

Others are expected to remain open, including:

  • Walmart
  • Ikea
  • Petco
  • Home Depot

Most of the stores closing on Sunday will reopen for regular business hours on Monday. 

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International

Gates-backed PhIII study tuberculosis vaccine study gets underway

A large study of an experimental vaccine for the world’s biggest infectious disease has finally kicked off in South Africa.
The Bill & Melinda Gates…

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A large study of an experimental vaccine for the world’s biggest infectious disease has finally kicked off in South Africa.

The Bill & Melinda Gates Medical Research Institute (MRI) will test a tuberculosis vaccine’s ability to prevent latent infections from causing potentially deadly lung disease. Last summer the nonprofit said it would foot $400 million of the estimated $550 million cost of running the 20,000-person Phase III trial.

It’s a pivotal moment for a vaccine whose origins date back 25 years when scientists identified two proteins that triggered strong immunity to the bacterium that causes tuberculosis. A fusion of those proteins, paired with the tree bark-derived adjuvant that helps power GSK’s shingles shot, comprise the so-called M72 vaccine.

Thomas Scriba

After decades of failures in the field, the vaccine impressed scientists in 2018 when GSK found that it was 54% efficacious at preventing lung disease in a 3,600-person Phase IIb study.

But the Big Pharma decided that a full-blown trial was too expensive to conduct on its own. Gates MRI stepped in to license the vaccine in early 2020, right before the Covid pandemic shifted global vaccine priorities towards the coronavirus, further stalling the tuberculosis shot.

“There’s been frustration that it’s taken so long to get this trial up and running,” Thomas Scriba, deputy director of immunology for the South African Tuberculosis Vaccine Initiative, told Endpoints News last summer.

At last, the vaccine is getting a chance to prove itself in a bigger study. If successful, it could lead to the first new shot for tuberculosis in over a century.

Emilio Emini, CEO of the Gates MRI, told Endpoints that the initial results may come in roughly four to six years. “Hopefully this will galvanize a refocus on TB,” he said. “It’s been ignored for many, many years. We can’t ignore it anymore.”

A substantial impact

Even though an existing vaccine helps protect babies and children against severe tuberculosis, the bacterium responsible for the disease still causes roughly 10 million new cases and 500,000 deaths each year.

Emilio Emini

By vaccinating adolescents and adults who test positive for infections but don’t have symptoms of lung disease, the Gates MRI hopes the shot will help prevent mild infections from becoming severe ones, curtail transmission of the bug, which is predominantly driven by people with lung disease, and reduce deaths.

“The impact would be substantial,” Emini said. But he cautioned that the biology behind mild and severe diseases is still mysterious. “The reality is that no one really knows what keeps it under control.”

The study, which will take place at 60 sites across seven countries, will include some people who are not infected with tuberculosis to ensure that the vaccine is safe in that broader population.

“Having to pre-test everybody is not going to make the vaccine easy to deliver,” Emini said. If the vaccine is ultimately approved, it will likely be used in targeted communities with high tuberculosis, rather than across a whole country, he added. “In practice, you would immunize everybody in those populations.”

Emini described the Gates MRI’s rights to the vaccine as “close to a worldwide license.” GSK retained rights to commercialize the vaccine in certain countries but declined to specify which ones.

A spokesperson for GSK said that the company “has around 30 assets under development specifically for global health … none of which are expected to generate significant return on investment.”

“It is not sustainable or practical in the longer term for GSK to deliver all of these alone. So we continue to work on M72, but in partnership with others,” the spokesperson added.

If the shot works, Emini said that the Gates MRI will sublicense it to a manufacturer that will be responsible for making and marketing the vaccine. The details are still being worked out, he noted.

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Government

Choosing over the counter drugs for COVID 19? It’s complicated

COVID-19 illness may include symptoms such as a sore throat, fever, cough and fatigue. In January, the United States Centers for Disease Control and Prevention…

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COVID-19 illness may include symptoms such as a sore throat, fever, cough and fatigue. In January, the United States Centers for Disease Control and Prevention (CDC) issued its most recent guidelines for the use of over the counter (OTC) drugs for COVID-19. Specifically, its guidelines state that most people with COVID-19 have mild illness and can recover at home while treating symptoms with OTC medicines such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil). 

Credit: Florida Atlantic University

COVID-19 illness may include symptoms such as a sore throat, fever, cough and fatigue. In January, the United States Centers for Disease Control and Prevention (CDC) issued its most recent guidelines for the use of over the counter (OTC) drugs for COVID-19. Specifically, its guidelines state that most people with COVID-19 have mild illness and can recover at home while treating symptoms with OTC medicines such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil). 

Researchers from Florida Atlantic University’s Schmidt College of Medicine and academic colleagues say it’s more complicated. They suggest that selecting an OTC medication to alleviate mild symptoms of COVID-19 should be based on the entire benefit-to-risk profile of the patient. Moreover, they say clinical decisions should be made by the health care provider for each of his or her patients.

In a review, published in The American Journal of Medicine, researchers take a closer look at both the potential benefits and risks of acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs) – such as ibuprofen, as well as aspirin for the selection of OTC drugs to treat mild symptoms of COVID-19.

Traditional nonspecific NSAIDs such as the shorter acting ibuprofen and longer acting naproxen have been used to treat COVID-19. These widely used OTC drugs reversibly and non-specifically inhibit both cyclooxygenase enzyme isoforms. This results in systematic reduction in the synthesis of prostaglandins resulting in anti-inflammatory and fever-reducing effects. The researchers caution, however, that both ibuprofen and naproxen have similar but greater side effect profiles than aspirin, such as gastroenteritis and peptic ulcers.

Acetaminophen is one of the most frequently used OTC drugs in the U.S. and worldwide as a treatment for fever, allergic symptoms, headaches, myalgia, symptoms of the common cold, and most recently COVID-19. Acetaminophen was originally marketed as an alternative to aspirin for treatment of mild to moderate pain based on reduced mucosal gastrointestinal side effects. The authors caution that even at daily doses of 4,000 milligrams per day, generally accepted as safe for adults, acetaminophen can be toxic to the liver and may result in the onset of acute liver failure. In the U.S., acetaminophen is the leading reason for calls to Poison Control Centers with more than 100,000 cases per year. These circumstances account for more than 2,600 hospitalizations and 450 deaths in the U.S. due to acute liver failure. 

Aspirin, or acetylsalicylic acid, inhibits the production of prostaglandins, which are responsible for mediating pain, inflammation and fever. The authors say that the beneficial effects of aspirin include anti-platelet, analgesic, antipyretic or anti-fever and anti-inflammatory properties. Aspirin is rapidly absorbed when taken orally and has a half-life of around four hours, after which it is mostly metabolized by the kidneys.

The researchers note that the anti-inflammatory benefits of aspirin should provide symptomatic relief of fever and body aches in COVID-19. They underscore, however, that health providers should view these in the context of the increased risks of bleeding, principally gastrointestinal. Further, COVID-19 itself may already predispose individuals to bleeding as well as to clotting abnormalities.

“We believe that health care providers should make individual clinical judgments for each of his or her patients in the selection of OTC drugs to treat symptoms of COVID-19. This judgement should be based on the entire benefit to risk profile of the patient,” said Charles H. Hennekens, M.D., Dr.PH, senior author, first Sir Richard Doll Professor and senior academic advisor in FAU’s Schmidt College of Medicine. “It is our belief that the individual health care provider knows far more about each of his or her patients than anyone, including expert members of guideline committees.”

The authors conclude that when the totality of evidence is complete, health care providers can make the most rational individual clinical judgements for their patients and policymakers for the health of the general public.

The authors believe that, at present, the totality of evidence is incomplete and requires reliable evidence from large- scale randomized trials designed a priori to do so, which is necessary to develop rational guidelines. They also believe that any guidelines should provide only guidance to health care providers. Currently, these considerations pose new clinical challenges for health care providers in prescribing OTC drugs to treat COVID-19. 

“The astute and judicious individual clinical decision making of health care providers for each individual patient based on all these considerations has the potential to do far more good than harm. Finally, guidelines should provide guidance to individual health care providers,” said Hennekens.

Study co-authors are Gage Collamore, a second-year medical student; Mark J. DiCorcia, Ph.D., an associate professor and associate dean for educational affairs and admissions; Yash Nagpal, a second-year medical student; and Larry Fiedler, M.D., a board certified gastroenterologist and an affiliate associate professor, all within FAU’s Schmidt College of Medicine; Michael A. Garone, M.D., a board-certified gastroenterologist and clinical assistant professor at George Washington University Hospital; and David L. DeMets, Ph.D., emeritus Halperin Professor and founding chair of biostatistics and informatics; and Dennis G. Maki, M.D., the Ovid O. Meyer Professor of Medicine; both at the University of Wisconsin School of Medicine and Public Health.

Hennekens and Maki served for two years as lieutenant commanders in the U.S. Public Health Service as epidemic intelligence service (EIS) officers with the CDC. They served under Alexander D. Langmuir, M.D., who created the EIS and directed the epidemiology program at the CDC, as well as Donald A. Henderson, M.D., chief of the Virus Disease Surveillance Program at the CDC. Langmuir and Henderson made significant contributions to the eradication of polio and smallpox using widespread vaccinations and public health strategies of proven benefit and had extraordinary collaborations with local, state, federal and international health authorities.   

– FAU –

About the Charles E. Schmidt College of Medicine:

FAU’s Charles E. Schmidt College of Medicine is one of approximately 157 accredited medical schools in the U.S. The college was launched in 2010, when the Florida Board of Governors made a landmark decision authorizing FAU to award the M.D. degree. After receiving approval from the Florida legislature and the governor, it became the 134th allopathic medical school in North America. With more than 70 full and part-time faculty and more than 1,300 affiliate faculty, the college matriculates 64 medical students each year and has been nationally recognized for its innovative curriculum. To further FAU’s commitment to increase much needed medical residency positions in Palm Beach County and to ensure that the region will continue to have an adequate and well-trained physician workforce, the FAU Charles E. Schmidt College of Medicine Consortium for Graduate Medical Education (GME) was formed in fall 2011 with five leading hospitals in Palm Beach County. The Consortium currently has five Accreditation Council for Graduate Medical Education (ACGME) accredited residencies including internal medicine, surgery, emergency medicine, psychiatry, and neurology.

 

About Florida Atlantic University:
Florida Atlantic University, established in 1961, officially opened its doors in 1964 as the fifth public university in Florida. Today, the University serves more than 30,000 undergraduate and graduate students across six campuses located along the southeast Florida coast. In recent years, the University has doubled its research expenditures and outpaced its peers in student achievement rates. Through the coexistence of access and excellence, FAU embodies an innovative model where traditional achievement gaps vanish. FAU is designated a Hispanic-serving institution, ranked as a top public university by U.S. News & World Report and a High Research Activity institution by the Carnegie Foundation for the Advancement of Teaching. For more information, visit www.fau.edu.


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