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Kathryn Edwards, M.D.

When it Comes to Vaccines, Kathy Edwards Calls the Shots

By John Howser
January 2010

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As the first global pandemic to be declared by the World Health Organization in nearly 40 years began to bear down on the United States, Kathryn Edwards, M.D., one of the nation’s leading vaccinologists, was tasked with executing a near miracle: quickly test the efficacy and safety of a new H1N1 vaccine.

Edwards delivered and delivered big.

Collaborating with seven other Vaccine Treatment and Evaluation Units, a group of the nation’s top vaccine research centers supported by the National Institutes of Health (NIH), Edwards, professor of Pediatrics and director of the Vanderbilt Vaccine Research Program, and her team of vaccine researchers completed the whole project without a hitch. At Vanderbilt they enrolled more than 300 volunteers and tested the new vaccine in three separate groups, completing these trials in less than two months. Another challenge met and another remarkable task accomplished.

“It is a source of pride to Vanderbilt that Kathy and her team were one of the groups selected to perform clinical trials for the H1N1 vaccine. Their expertise was called upon when the nation needed them, and they responded completely,” said William Schaffner, M.D., professor and chairman of the Department of Preventive Medicine and a longtime colleague.

As testament to the high-energy approach to her work, perhaps forged during her Midwestern upbringing in Iowa, Edwards has led a seemingly countless number of trials for just about every infectious disease for which an effective vaccine exists. Over the course of a 30-year career at Vanderbilt, she has tested vaccines for H5 avian flu, pertussis, pneumococcus, smallpox, anthrax and numerous others. The list amounts to a veritable rogue’s gallery of infectious disease pathogens.

As Schaffner noted, she is a great example of someone whose focus is always on what’s good for patients rather than a particular pathogen.

“Dr. Edwards is a classic ‘triple-threat’ academic physician-scientist. She is a skilled and empathetic clinician, a gifted teacher and mentor who can motivate trainees, whether they are young novices or more experienced professionals, as well as being an indefatigable original investigator who can frame questions that go to the heart of the question at issue,” Schaffner said. “Also, she is fun to be around with a quick sense of humor!

“Dr. Edwards’ research has focused on preventing disease, medicine’s highest goal. Her reward is that classical infectious diseases of childhood such as polio, Haemophilus influenzae B and pertussis have been eliminated or are on the wane. Her joy is that she can focus on the next target like malaria.”

In order to amass such a body of work she is always in motion. She walks briskly through the halls of the Medical Center as she makes her way from her office in Medical Center North, to the Clinical Research Center, to her pediatric patients at the Monroe Carell Jr. Children’s Hospital at Vanderbilt. She moves and speaks with purpose.

While her career was blossoming into the role of one of the nation’s eminent vaccine researchers, Edwards never let go of her ties to patient care and teaching, still seeing patients on a regular basis and mentoring a vast number of up and coming pediatric researchers over the years.

“I still really like taking care of patients. It’s something that I do that helps make the rest of my work seem relevant. I feel that’s why I’m still a doctor because I want to help sick people get well,” Edwards said. “But through research you don’t just take care of one patient; you take care of a whole cadre of patients.

“Besides, being a pediatrician has been one of the good things I’ve done that has really helped my career. By and large, if you are a person who has kids routinely vomiting and peeing on you, it’s hard to be incredibly self-important,” she said with a laugh.

Kathy Edwards, M.D., interviews Mary West, an H1N1 vaccine study volunteer. Photo by Joe Howell.

Kathy Edwards, M.D., interviews Mary West, an H1N1 vaccine study volunteer. Photo by Joe Howell.

It was through these years of hard work, trial and error, and conducting large-scale vaccine studies that prepared Edwards to succeed on the pressure-packed mission of testing the H1N1 flu vaccine in such a short period of time. The experience taught her the importance of making participation in a study as convenient and rewarding as possible for the volunteers – even if it wasn’t for her.

“When I first began my career in clinical research, I thought that the public would be interested in participating in studies simply because they answered important scientific questions,” she said. “However, after the initial years, when it was extremely difficult to conduct studies without incentives, I added a financial incentive and also made every effort to make it easy for the subjects to comply. This included meeting subjects at hours convenient to them and not to me, arranging transportation if needed, and making study participation as easy as possible for them.

“It was about making needed sacrifices for the participants, it was about finding ways to circumvent obstacles and turn them into opportunities.”

Edwards identifies the five key functions of her work as: performing government-funded research, serving on advisory committees that translate clinical research findings into practice and public policy, serving as a mentor to young investigators, caring for patients, and teaching medical students about pediatric infections.

“The biggest reason I came to Vanderbilt was Kathy,” said Buddy Creech, M.D., M.P.H., assistant professor of Pediatrics. “When I was in medical school, one of my deans, when I asked where I should go for residency, suggested that I should go to Vanderbilt, sit at Kathy’s feet, and learn everything she knows.”

Creech is now a research collaborator with Edwards, with an office next door, and is a rising star in his own right within the field of pediatric infectious diseases.

“Kathy has an uncanny way of mentoring young physicians to their strengths. For me, that meant telling me as a first-year fellow, ‘we should do grand rounds on MRSA.’ What I didn’t yet understand is that in mentor language, ‘we’ meant that I should do grand rounds on MRSA. The fear and trepidation of giving grand rounds soon transitioned to excitement and confidence as I immersed myself in the literature and planned the talk with Kathy,” Creech said.

“At the end of the day, Kathy has not only provided me with a scientific career path, she also began the process of teaching me what it meant to be a physician-scientist with an expertise in a specific area. Her enduring legacy will not only be the vaccine studies she has led or the new discoveries in pediatric infectious diseases she has made; rather, her lasting influence in the field will be the vast number of people who consider her their ‘academic mother,’ providing guidance, support, encouragement, and sometimes a motherly nudge when appropriate.”

Edwards says the key to her long success as a vaccine researcher has to do with teamwork, specifically picking the right team. Her advice for young investigators is to find collaborators who have a reputation for doing what they say they will do, work well with others, show respect for their colleagues and meet deadlines.

“Kathy never hesitates to jump in the trenches with the rest of her staff to recruit, enroll, and maintain the safety of the volunteers in our clinical trials,” said Debbie Hunter, R.N., B.S.N., clinical trials recruitment coordinator in Pediatric Infectious Diseases. “I have worked for many medical professionals in my 17 years of nursing, and I have never been as fortunate as I am now. Kathy has a special ability to give you the confidence and support to help you achieve the goals you set for yourself.”

Hunter offers a colorful, yet highly accurate account of the frantic pace at which Edwards frequently works. “On a recent conference call with the NIH, Kathy jumped up and whispered to us that she must leave to catch a plane. Not wanting to miss any details from the call, Kathy called back from her cell phone once outside the building. During a moment of silence on the call we heard ‘that sounds good’ as Kathy joined back in. This was followed shortly by, ‘I’m sorry. I’m walking somewhere to get somewhere,’” Hunter said.

Edwards says she is particularly intrigued by finding ways to circumvent obstacles. “As an only child who was very willful, I generally would not take ‘no’ for an answer,” she said. “I find that trait has been extremely important to the success of my clinical research. The more challenging the question or difficult the obstacle, the more I am intrigued to solve it.”

The first big challenge Edwards tackled after joining Vanderbilt’s faculty was testing a brand new diphtheria, tetanus and pertussis (DTP) vaccine. The original DTP vaccine had many side effects, including high fevers and even seizures in a small percentage of children. The problem was so pervasive, many parents, particularly in Japan and the United Kingdom, would no longer allow their children to receive the vaccine. As a result, the incidence of pertussis, also known as whooping cough, began to rise dramatically in the late 1970s and into the 1980s, and so did deaths associated with the disease.

An added consequence from the vaccine’s poor safety profile was an enormous number of lawsuits. As a result of bad press and related lawsuits, testing a suitable new DTP vaccine in children presented a significant recruitment challenge. However, the problem presented an opportunity. As a result there was a lot of money infused into the system to create new vaccines thus providing the first major research opportunity in Edwards’ budding career.

“We gave a new DTP vaccine that was manufactured in Japan first to adults and then to children in a Phase 1 trial. We even made home visits to some of the volunteers so they would participate. The safety profile for the new vaccine was really smashing, much, much better,” she said. Edwards followed the DTP vaccine through Phase II and into successful completion of Phase III, NIH-funded trials.

This experience and countless other trials have given Edwards a wealth of knowledge.

“My golden rule of clinical trials is that it is very important to never be too good to do what you ask of others. In one of the H1N1 trials we enrolled 150 people in five days. We worked from six in the morning until 10 at night. But we were all working together. Don’t ask people to do things you won’t do yourself. It’s empowering for them to see you share in the work,” she said. “My other golden rule is that an investigator needs to be able to perform all aspects of the work.”

Recently, while speaking with a group of admiring young investigators eager to glean secrets of her success, Edwards spoke of what she calls the “bottom line” about the public’s perception of vaccines.

“The better we do our work and the better the vaccine, the disease goes away. Then people tend to forget about the disease and think it wasn’t too bad. But if we stop vaccinating then the disease will come back. So it’s a delicate balance between safety and perception,” she said. “Vaccines are all about risks versus benefits. The best vaccines prevent bad diseases. When the disease itself is reduced, then it is possible for adverse vaccine events to occur more often than the disease it is meant to prevent.”

With impressive enthusiasm and an enviable level of energy, Edwards still has much work to do, more vaccine trials to conduct and more people to protect from the scourge of disease. She could rest on her laurels, having already made significant contributions to the field of infectious diseases prevention. But her desire for further successes propels her forward.

“Kathy Edwards is that rare blend of compassion, intellect and drive that makes Vanderbilt University great,” said Jonathan Gitlin, M.D., assistant vice chancellor for Maternal and Child Health Affairs, chair of Pediatrics and physician-in-chief of the Monroe Carell Jr. Children’s Hospital at Vanderbilt.

“While she is humble and self-effacing about her own work, it is important to realize that through her creativity and passion vaccine science has been advanced, lives have been saved and a generation of young pediatricians has been educated.”

For her next major project Edwards and her team are going to begin a new U.S. Centers for Disease Control and Prevention-funded pneumonia study which will enroll 1,300 adults and children with pneumonia who are admitted to area hospitals.

“Although I have not worked with these other hospitals before, I am seeking new ways to convince the physicians and nurses at those hospitals that the study is important and that they will benefit in participation,” she said. “It is about finding win-win opportunities for all involved. It will be a challenge but one that will keep me coming to work each day, eager to solve new problems.”

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