Amidst the tumult in the nation’s capital, a quieter reckoning was taking place this week for the Moderna COVID-19 vaccine clinical trial. Lab Land has been hearing from Emory-affiliated study participants that they’re finding out whether they received active vaccine or placebo.
For example, Emory and Grady physician Kimberly Manning, who had written about her participation in the Moderna study in a Lancet essay, posted on Twitter Tuesday. She discovered she had received placebo, and then was offered active vaccine.
“Companies have said that they feel an ethical obligation to deliver vaccine to placebo recipients; the FDA and experts at its advisory panel have debated whether this obligation even exists. Instead, they argue, offering vaccine to volunteers receiving placebo limits the quality of the data about the vaccine’s long-term efficacy and side effects.”
A plan to keep participants in the study under a blinded crossover design was floated, but not implemented. Some participants have said they sensed from the start, based on temporary unpleasant side effects, whether they had received active vaccine or placebo.
â€œSepsis is largely a face without a name in the EMS setting, â€œ Polito says. â€œThe goal of our study was to create a tool to assist EMS providers in naming this deadly condition at the point of first medical contact. Similar to other life-threatening, time-sensitive conditions like stroke and heart attack, naming sepsis is the first step in developing coordinated care pathways that focus on delivering rapid, life-saving treatment once the patient arrives at the hospital.â€
Biomarkers circulating in the bloodstream may serve as a predictive window for recurrent stroke risk and also help doctors accurately assess what is happening in the brains of patients with acute traumatic brain injury (TBI).
Michael Frankel, MD
Researchers at Emory University School of Medicine, led by principal investigator Michael Frankel, MD, Emory professor of neurology and director of Grady Memorial Hospitalâ€™s Marcus Stroke & Neuroscience Center, are studying biomarkers as part of two ancillary studies of blood samples using two grants from the National Institutes of Health.
In the $1.47 million, four-year grant called â€œBiomarkers of Ischemic Outcomes in Intracranial Stenosisâ€ (BIOSIS), Emory researchers are analyzing blood samples from 451 patients from around the country who were enrolled in a study known as SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis), the first randomized, multicenter clinical trial designed to test whether stenting intracranial arteries would prevent recurrent stroke.
Researchers in the SAMMPRIS study recently published their results in the New England Journal of Medicine, showing that medical management was more effective than stenting in preventing recurrent strokes in these patients. Frankel’s BIOSIS research team is using blood samples from these same patients to continue learning more about the molecular biology of stroke to predict risk of a stroke occurring in the future.
â€œOur goal is to learn more about stroke by studying proteins and cells in the blood that reflect the severity of disease in arteries that leads to stroke. If we can test blood samples for proteins and cells that put patients at high risk for stroke, we can better tailor treatment for those patients,â€ says Frankel.
Patients with narrowed brain arteries, known as intracranial stenosis, have a particularly high risk of disease leading to stroke. At least one in four of the 795,000 Americans who have a stroke each year will have another stroke within their lifetime. Within five years ofÂ a firstÂ stroke,Â the risk for another stroke can increase more than 40 percent. Recurrent strokes often have a higher rate of death and disability because parts of the brain already injured by the original stroke may not be as resilient.
The other study, â€œBiomarkers of Injury and Outcome in ProTECT IIIâ€ (BIO-ProTECT)” is a $2.6 million, five-year NIH grant in which Frankelâ€™s team will use blood to determine what is happening in the brain of patients with acute TBI.Â The blood samples are from patients enrolled in the multicenter clinical trial ProTECT III (Progesterone for Traumatic brain injury, Experimental Clinical Treatment), led by Emory Emergency Medicine Professor, David Wright, MD, to assesses the use of progesterone to treat TBI in 1,140 patients at 17 centers nationwide.
In the BIO-ProTECT study, Emory is collaborating with the Medical University of South Carolina, the University of Pittsburgh, the University of Michigan and Banyan Biomarkers.
TBI is the leading cause of death and disability among young adults in the US and worldwide. According to the Centers for Disease Control and Prevention, approximately 1.4 million Americans sustain a traumatic brain injury each year, leading to 275,000 hospitalizations, 80,000 disabilities, and 52,000 deaths.
Acute TBI leads to a cascade of cellular events set in motion by the initial injury that ultimately lead to cerebral edema (swelling of the brain), cellular disruption and sometimes death. Tissue breakdown leads to the release of proteins into the bloodstream. These proteins may serve as useful biomarkers of the severity of the injury and perhaps provide useful information about response to treatment.
Using the large patient group in the ProTECT III trial, the researchers hope to validate promising TBI biomarkers as predictors of clinical outcome and also evaluate the relationship between progesterone treatment, biomarker levels and outcome.
â€œIf we can better determine the amount of brain injury with blood samples, we can use blood to help doctors better assess prognosis for recovery, and, hopefully whether a patient will respond to treatment with progesterone,â€ says Frankel.
As parents we hope all babies are born with a healthy start in life, after a full 37 â€“ 40 weeks in the womb. Sadly, every year more than half a million babies are born prematurely in the United States. The rate of premature birth has risen by 30 percent since 1981 according to the March of Dimes. Itâ€™s not clear why some babies are born before full gestation – before their lungs, brains or other organs are fully developed. Thousands donâ€™t live to celebrate their first birthday as a result.
In Georgia more than 400 babies are born too soon each week.Â Dr. William Sexson, a neonatologist and professor of pediatrics at Emory University School of Medicine and March of Dimes Prematurity Campaign Chair witnesses the effects of preterm birth every day.Â He says, â€œPremature birth is the leading cause of infant mortality. Babies born just a few weeks too soon are at increased risk for newborn health complications, such as breathing problems, can face serious health challenges and are at risk of lifelong disabilities.â€
On Saturday April 30, 2011, a legion of more than 10,000 families and business leaders from across Georgia will band together for the March of Dimes annual â€œMarch for Babies.â€ With more than 30 â€œMarch for Babiesâ€ events planned throughout the state, the annual affair is the nationâ€™s oldest walk fundraiser dedicated to preventing premature birth, birth defects and infant mortality.
â€œMarch for Babiesâ€ supports research and educational programs aimed at helping women have healthy babies. Funds raised from the â€œMarch for Babiesâ€ event will support prenatal wellness programs, critical research and community grants, along with local resources such as the Angel II neonatal transport unit at Grady Memorial Hospital.
Most pregnancies last around 40 weeks. Babies born between 37 and 42 completed weeks of pregnancy are called full term. Babies born before 37 completed weeks of pregnancy are called premature. â€œWomen who have hypertension and diabetes are at higher risk to have preterm babies or babies with health problems,â€ says Sexson.
According to the March of Dimes, the most urgent infant health problem in the U.S. today is premature birth. It affects more than half a million babies each year and is the leading cause of newborn death within the first month of life. Last November, the March of Dimes issued a Report Card on Premature Birth, giving the nation a â€œDâ€ and Georgia, the grade of â€œF.â€Â Sexson adds, â€œWe have a long way to go before all babies in America get a healthy start in life and we are committed to working with state health officials, hospitals and health care providers to continue to fight for preemies.â€
The March of Dimes is the leading nonprofit organization with its mission to improve the health of babies by preventing birth defects, premature birth and infant mortality.
For more information, or to participate in â€œMarch for Babiesâ€ visit marchofdimes.com.
Nadine Kaslow, PhD, Emory psychologist and professor in the Department of Psychiatry and Behavioral Sciences at Emory, has learned a lot about Intimate Partner Violence (IPV) over the last two decades. In the 1990â€™s, Kaslow began the development of a program that was eventually named the â€œNia Project.â€
Nia is a counseling program for abused and suicidal African American women, funded by grants from the Centers for Disease Control and Prevention (CDC) and the National Institute of Mental Health. The name comes from the Kwanzaa term that means “purpose.”
Nia serves countless numbers of abused (click site for information on domestic abuse) and suicidal women who come through Atlantaâ€™s Grady Memorial Hospitalâ€™s emergency department each year. The women come in with black eyes, broken bones, and broken spirits, often inflicted by the people who are supposed to love them the most: their husbands, boyfriends and partners.
According to the CDC, Intimate Partner violence resulted in more than 1,500 deaths in the United States in 2005.Â Statistics from the Commission on Domestic Violence show that African American females experienced intimate partner violence at a rate 35 percent higher than that of white females, and about 22 times the rate of women of other races. The number one killer of African American women ages 15 to 34 is homicide at the hands of a current or former intimate partner.
Many people know that heart disease is currently the number one killer of women in the United States. But a little more than a half a century ago it was widely believed that cardiovascular disease only affected men. Renowned cardiologist, Nanette K. Wenger, MD, challenged this theory and thanks to her pioneering efforts over the last 50 years women today know better.
2010 Georgia Woman of the Year, Nanette K. Wenger, MD
Wenger, a professor of medicine in the division of cardiology at Emory University School of Medicine and former chief of cardiology at Grady Memorial Hospital, is being honored as the 2010 Georgia Woman of the Year for her lifetime commitment to reducing womenâ€™s disability and death from cardiovascular disease.
She joins the ranks of other distinguished Georgia women including First Lady Rosalynn Carter who was named the first Georgia Woman of the Year in 1996 by the Georgia Commission on Women. In addition to this prestigious accolade, Wenger has accumulated dozens of awards throughout her celebrated career including the Lifetime Achievement Award from the American College of Cardiology in 2009. She is a sought after lecturer for issues related to heart disease in women, heart disease in the elderly, cardiac rehabilitation, coronary prevention and contemporary cardiac care.
Kimberly Manning, MD, Lisa Bernstein, MD, and William Branch, MD, leading the way
Kimberly Manning, MD, an internist at Grady Memorial Hospital who directs Emory’s Transitional Year Residency Program, asks her residents to write about an experience – good or bad – that made a lasting impression on them.
Manning herself regularly writes about her experiences as a doctor. She calls it “habitual reflection” and believes that the practice is vital to developing good doctors. She regularly asks herself about interactions with patients and imagines herself in their place. What was the patient feeling? How would I feel in the same situation? Did the patient process everything I said?
These are the kinds of questions she wants medical students and residents to ask themselves regularly. By examining experiences that were rewarding, saddening or even frustrating, they can become better doctors, she says in the new issue of Emory Medicine magazine.
Nadine Kaslow, PhD, Emory School of Medicine professor of psychiatry and behavioral sciences, founded in the early 1990s the Grady Nia Project for abused and suicidal African-American women. Named for the Kwanzaa term that means “purpose,” Nia serves countless numbers of abused women who come through Grady Memorial Hospital’s emergency department each year.
Kaslow says the women in the Nia program, who either feel suicidal or have attempted suicide because of stress associated with violence, are victims of intimate partner violence and are usually black, minimally employed, with children and addicted to drugs and alcohol. Many are homeless.
Nia is staffed 24/7. Some staffers may make a trip to the emergency department in the middle of the night when a woman comes in with injuries or a story consistent with intimate partner violence or when she has attempted suicide. If a woman enrolls in the program, she will join approximately 50 to 75 other women who are going through it at any given time.
Vivian Pinn, MD, associate director for research on womenâ€™s health, and director of the Office of Research on Womenâ€™s Health at NIH, opened the meeting with Emoryâ€™s conference chair, Nanette Wenger, MD, professor of medicine (cardiology), Emory School of Medicine, and chief of cardiology at Grady Memorial Hospital.
Nanette K. Wenger, MD
In a career that spans more than 50 years, Wengerâ€™s dedication to reducing womenâ€™s disability and death from cardiovascular disease has made her one of the countryâ€™s most-respected experts on coronary heart disease in women. In 2009, Wenger received the Lifetime Achievement Award from the American College of Cardiology.
Although Wenger has earned dozens of awards in her celebrated career, she says her greatest professional achievement has been to help change a major paradigm in cardiology: the assumption that heart disease affects only men. A half a century ago heart disease was thought of as a “man’s disease.”