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CU’s AIDS Clinical Trials Unit celebrates 25 years of progress

Diagnosed in 1991, David Dillon was sure his HIV-positive test was a death sentence. He’d watched friends die, struggling on the only drugs available at the time, medications that had intense side effects and were barely effective, with the rapidly evolving AIDS virus building resistance to them often within months.

But then the words of a social worker resonated in his mind. Experts, she had told him soon after hearing his diagnosis, were on the verge of turning the once always-deadly affliction into a chronic but manageable disease. “That’s what I grabbed on to right away,” Dillon said. “And that’s what I’ve hung on to ever since.”

Dillon was one of the first HIV-positive patients to volunteer for studies with the AIDS Clinical Trials Unit (ACTU) at the now University of Colorado Anschutz Medical Campus. Today, as the ACTU celebrates 25 years of major contributions in revolutionizing HIV/AIDS treatment, Dillon is still alive, grateful for CU and content knowing he helped make a difference.

Creating a top-notch program

The human-immunodeficiency virus (HIV), which spread fear and bias throughout the country in the ‘80s, killing people from actor Rock Hudson to writer Isaac Asimov, had no treatment until 1987, and no effective drugs until the mid-‘90s. CU eventually became one of the top research universities for HIV/AIDS research in the world, but not until netting a major new faculty recruitment.

AIDS patient David Dillon
David Dillon has set a goal of outliving his new pup, Finn.

“It was a big deal,” Thomas Campbell, MD, principal investigator of CU’s ACTU, said of the 1989 recruitment of Robert “Chip” Schooley. A Harvard Medical School professor and prominent, internationally-recognized HIV researcher, Schooley established CU as an AIDS Clinical Trials Center, bringing front-line drugs to the region.

“I remember sitting on my back porch and reading about his recruitment on the front page of The Denver Post,” said Campbell, who was an infectious disease fellow at the time. “Bringing him to Colorado was like recruiting John Elway to the Denver Broncos. It’s bringing a superstar to Colorado, which helps elevate the whole team.”

By 1991, when Dillon, a Housing Department employee at CU Boulder at the time, was learning of his infection, the National Institutes of Health was tapping Schooley to lead a new ACTU, injecting $4.8 million in adult AIDS research and $3 million in pediatric AIDS research into CU’s coffers. CU’s unit joined a growing number of national sites within the AIDS Clinical Trials Group (ACTG), formed in 1986 as the urgency for new drugs intensified.

“Schooley was the key person that made that happen, and so all of the great HIV/AIDS research capacity that we have today is largely possible because of the groundwork that he laid and the foundation that he built in the early ‘90s,” said Campbell, who had joined CU as an infectious disease fellow that year and is now medical director of the adult Clinical and Translational Research Center (CTRC) of the Colorado Clinical Translational Science Institute at CU, where clinical trials are conducted.

For many Colorado HIV patients, including Dillon, the move was a life-saving boon.

Road past resistance is long

Wearing a beeper, which interrupted him every four hours to take his arsenal of pills, Dillon, now 65, was one of the lucky ones in that the regimen’s side effects didn’t make him so sick he ditched the AZT (azidothymidine), choosing to accept HIV’s fate. But he knew the drug’s effects were waning.

‘It seemed like I was already at the cusp, so when a drug came into testing, I was ready for it. Dr. Steven Johnson saved my life more than once.’ – patient David Dillon

Dillon found Graham Ray, RN, still a study coordinator with CU’s ACTU, and signed up for one of the first of what would exceed 177 clinical trials in the unit’s 25 years, with more than 2,500 participants coming forward to help scientists in their search for a more effective treatment.

The study involved spending some nights in the hospital, and Dillon recalled a trial patient in a nearby bed. “He had pretty much run the gamut of drugs available. He’d run out of options, so this trial was one of his last hopes,” Dillon said. “I lost several friends that were in the same boat. There just wasn’t new treatment coming fast enough to help them.”

Few drugs and rapid resistance were major problems for patients in those days,” Campbell said. “We could only give one or two drugs at the most together, and drug resistance developed very rapidly. The medicines lost their effectiveness.”

For Dillon, who estimates he tried upwards of 20 single experimental drugs, the trials always came right in time, with Ray and his CU doctor, Steven Johnson, MD, of the Division of Infectious Diseases, regularly alerting him to new studies.

“It just seemed like I was already right at the cusp, so when a drug came into testing, I was ready for it,” said Dillon, who still travels to CU Anschutz from his Loveland home, indebted to his caregivers. “Dr. Johnson saved my life more than once,” said Dillon, who has AIDS, the end-stage disease of an HIV infection.

HIV attacks patients’ immune systems by binding to and killing CD4 cells, which are largely responsible for fighting infections. Doctors monitor CD4-cell counts, assessing the progression of the disease. If a patient’s count falls below 200, then they are diagnosed with AIDS, and their risk of deadly infections rises. Dillon’s counts were once as low as five.

Trial volunteers join mission

AIDS patient Patrick Terry
Patrick Terry has been an integral member of the International Gay Rodeo Association for 30 years.

For Patrick Terry, a former Colorado rodeo staple and Denver-area native, who has done “probably a dozen” trials with CU since 2000, taking part in trials is about staving off AIDS (his CD4 count has never fallen below 500), and putting an end to the epidemic. “To me, it’s so important that we find out more about it, and if there’s any chance that there could be a cure, then I’d like to be a part of it.”

Helping science isn’t always easy, said Dillon and Terry, 60, who calls himself a go-to volunteer for ACTU research nurse Cathi Basler, RN, because of his dedication to the trial process. Although he said he’s “lucky” to have apparently always received the active drug in the double-blind studies, Dillon recalled a nearly five-year trial that required injecting a drug in his abdominal muscles twice a day.  “It just hurt, and you had to just keep doing it.”

“You know when you are on the real drug,” said Terry, who has volunteered for clinical trials with Basler for years after being diagnosed with HIV in 1995. “I’ve had some very difficult studies,” he said, noting one in which the drug was so strong, it caused hallucinations, and another in which he had to have lymph nodes removed.

But the pair’s dedication has paid off, for them, and for many of the more than 30 million people worldwide living with HIV.

Treatment only works with adherence

In 1996, a CU ACTU-led research study played a key role in the development and widespread use of what was commonly termed “drug cocktails.” That was a major turning point in HIV/AIDS treatment, Campbell said.

“When we first really had the ability to put three drugs together to make an effective combination, it greatly reduced the risk of drug resistance. It did so by having much more effective suppression of viral replication,” he said. “We suddenly had a way to effectively treat HIV and prevent all the damage it does to the body.”

AIDS patient David Dillon at CU Anschutz
David Dillon, one of the first HIV-positive patients to volunteer for studies with the AIDS Clinical Trials Unit, is indebted to his caregivers at the CU Anschutz Medical Campus. He still travels regularly to CU Anschutz from his home in Loveland.

Part of a two-drug combination trial today, Terry’s CD4 counts hover around 1,000, and his viral load is undetectable. For, Dillon, although his CD4 counts aren’t quite so high, and his “cocktail” includes five drugs, his viral load is also undetectable.

But Terry, emphasizing that the effective drugs are still not a cure, advocates for medication adherence. “I’ve never missed a dose, and that’s probably one of the most important things,” said Terry, , who watched his “little brother” die in 2005, after living in denial with an HIV infection for years and succumbing to AIDS within 18 days of hospitalization.

“Take it seriously,” Terry said. “Don’t skip your medicine. That’s a problem with so many people. The medicine doesn’t work if you don’t take it. And take care of yourself,” he said, adding that he stopped drinking at diagnosis and keeps an eye on fitness.

Workload for researchers still great

While noting the great scientific achievements, which would not have been possible without dedicated volunteers, Campbell, too, emphasized that HIV remains a serious virus with no cure. “Yes, a person diagnosed today who seeks treatment early and adheres to it should live a near-normal lifespan,” Campbell said. “But near normal is not normal. There’s still a lot of work that needs to be done.”

The to-do list for HIV/AIDS researchers remains long, with vaccine trials still underway, and development of a cure feasible but probably not within close reach, Campbell said. Continuing efforts to treat HIV patients in developing countries remains a priority, as does boosting prevention education.

For instance, use of an antiretroviral drug combination called PrEP in high-risk individuals who are not yet infected can reduce their chances of contracting HIV, and early treatment in patients already infected can not only boost their chances of success; it reduces the virus’s spread, Campbell said. “So we not only help them, but we help the rest of the community.”

Dillon said he’s grateful for that first social worker’s hopeful words and for finding the ACTU at CU at the right time. “It saved my life, and it saved a lot of other lives.”

Photo at top: Constance Benson, MD, Robert “Chip” Schooley, MD, and Thomas Campbell, MD, attended a recent Zimbabwe Art and Sculpture Auction in the Fulginiti Pavilion.

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Skin pigmentation far more complex than previously known

Researchers examining understudied populations in Africa have found that skin pigmentation is far more varied and complex than previously understood. And that complexity increases nearer the equator.

Associate Professor Chris Gignoux of the Colorado Center for Personalized Medicine is co-author of
Associate Professor Chris Gignoux of the Colorado Center for Personalized Medicine at CU Anschutzx is co-author of the study.

“Previous studies have focused on more homogeneous European and Eurasian populations and concluded that pigmentation was governed by just a handful of genes,” said study co-author Christopher Gignoux, PhD, MS, associate professor at the Colorado Center for Personalized Medicine at the University of Colorado Anschutz Medical Campus. “But in this study we looked at pigmentation among African populations and found a striking variability that has been underappreciated.”

The study, published in the November edition of the journal Cell, is the culmination of a decade’s worth of research involving scientists from CU Anschutz, the State University of New York at Stony Brook, Stanford University, Stellenbosch University, and the Broad Institute of MIT and Harvard.

The researchers studied two populations of the KhoeSan people, the Khomani San and the Nama. Both live in South Africa and have much lighter skin than other Africans who live closer to the equator.

Scientists conducted interviews, recorded height, age and gender and used a reflectometer to measure skin color of about 400 people. They discovered that skin pigmentation is highly heritable but that doesn’t explain its variance and complexity. Instead of a few genes controlling the process as many thought, they found far more genes involved, each one contributing something different. And many of the genes have yet to be discovered. Only about 10 percent of that previously discovered variation can be linked to genes impacting pigmentation in the KhoeSan.

One finding showed that the closer a population moves to the equator, the more genes come into play that can influence variability.

“Light skin pigmentation in the KhoeSan appears to be due to a combination of many small-effect mutations as well as some large-effect variants,” said the study’s senior author Brenna Henn, assistant professor of ecology and evolution at SUNY Stony Brook.

Some of those mutations, Henn said, may have arisen in southern Africa more than 100,000 years ago and were selected for in Europeans after they left Africa for higher latitudes where pigment lightens to absorb more sunlight which produces vitamin D and folate protection.

The researchers studied two populations of the KhoeSan people, the Khomani San and the Nama. Both live in South Africa
The researchers studied two populations of the KhoeSan people, the Khomani San and the Nama. Both live in South Africa.

“We argue that the distributions of skin pigmentation globally suggest different forces of selection operating at various latitudes,” Henn said.

In order to understand baseline pigmentation, she said, it’s important to study a large set of genetically diverse populations that have historically been exposed to different levels of ultraviolet radiation.

Gignoux agreed saying earlier notions of skin pigmentation being relatively simple underestimated the genetics involved.

“At higher latitudes there is far less difference in skin pigmentation and that’s where most of the earlier research was done,” he said. “But there is more pigmentation variation on the African continent than any other place on earth and its needs further study.”

 

 

 

 

 

 

 

 

 

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Memorial remembers Traystman as a respected scientist, cherished friend

Although his office now sits empty, a rarity during his 10 years with the University of Colorado, Richard “Dick” Traystman, PhD, lives on through his legacy. He built a successful research program, guided countless colleagues and mentored students toward greatness.

Richard Traystman memorial
Richard Traystman, PhD, where he spent countless hours – at his desk.

Such was the message delivered during a “Celebration of Life” on the CU Anschutz Medical Campus for the distinguished professor and vice chancellor for research, who passed away Oct. 19 at 75.

More than 250 campus community members, welcomed by CU Anschutz Chancellor Don Elliman, gathered on Nov. 7 to reminisce about a man whose colleagues say led with both fortitude and compassion, serving as a revered mentor and a treasured friend to many.

When people leave this earth, they leave a lot of holes in other people’s lives, said Professor Robert Damrauer, associate vice chancellor for research housed at CU Denver, after sharing his and Traystman’s love of opera.  “There are going to be holes in all kinds of people’s lives.”

‘We can do more’

Richard Traystman in the kitchen
Traystman was remembered as a consummate team leader. Here, he pitched in cooking a meal.

CU Denver Chancellor Dorothy Horrell recalled her first meeting with Traystman, PhD, and being struck by his “booming” voice and straight-forward demands for high standards. “But I found that once Dick took you into his fold, he became an ardent advocate, a trusted confidant, a sage resource and a cherished friend.”

Well-loved for his wit and generosity, Traystman also bolstered colleagues and students in their own careers by modeling passion and strong work ethic, his friends said, noting that he was always the first to come and last to leave the office and was a fixture on Saturdays.

“I asked him once when he usually leaves,” said Vesna Jevtovic-Todorovic, MD, PhD, a colleague in the Department of Anesthesiology. “And his response was that Suzann (Lupton), his devoted and very supportive wife, made that decision for him.”

His work ethic stemmed, at least in part, from his sheer love of his job, his colleagues said. “He worked extremely hard, but it was never work to him as he enjoyed it all too much,” said Alison Lakin, RN, PhD, associate vice chancellor for regulatory compliance.

“But most importantly of all, he created not a team but a family that supported each other and could have fun,” Lakin said, choking back tears. “We all know the most important role we can play is to make sure the research keeps moving forward. Thanks to his great leadership and legacy, I know that it will.”

‘We can do better’

Traystman had a talent for spotting human potential and motivating colleagues and students, for whom he had a special affection, Horrell said. “He would engage so deeply with students, ask thoughtful questions, and always leave them with an encouraging word.”

Portrait of Richard Traystman
Richard “Dick” Traystman, PhD

CU wanted him for his science, his ability to bring people together and for his personality, which it really needed at the time, said former School of Medicine Dean Richard Krugman, MD. When Traystman was recruited, the campus was moving to Aurora from central Denver and facing other struggles.

“It looked to me that Dick was being recruited for an impossible job,” Krugman said. But he gathered a terrific group of people and overcame the struggles, all while he kept up his own lab and research funding and traveled the world earning a Lifetime Achievement Award, Krugman said. “No one person could ever do this,” he said.

Traystman’s dedication never waned, not even at the end, his colleagues said. “During my final visit with him at the hospital, I thanked him for all he had done, the way he had touched so many lives, for his support of CU Denver, and for his belief in me,” Horrell said. “True to form, he had something to say: that our work wasn’t yet done. We can do more,” he told her. “We can do better.”

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Project takes AIM at rural students’ health and wellness

Elaine Belanksy of Rocky Mountain Prevention Research Center
Elaine Belansky, PhD, Rocky Mountain Prevention Research Center director, and co-principal investigator

After years of partnering with K-12 schools in the most impoverished area of the state, enhancing exercise and nutrition programs for healthier learning, a Colorado School of Public Health research team on the University of Colorado Anschutz Medical Campus has gained more than $3.5-million in funding to take its project to the next level.

Researchers with the Rocky Mountain Prevention Research Center were recently awarded two grants from The Colorado Health Foundation (TCHF) to continue their work in southeastern Colorado and San Luis Valley schools. The money allows for a significant expansion of the center’s strategic planning process, Assess, Identify, Make it Happen (AIM XL), through which district-level comprehensive health and wellness plans can be developed.

“What is most exciting to me is that this grant gives us a chance to continue our longstanding partnerships with these rural school districts and to expand our work to now support children’s emotional health in addition to physical activity and healthy eating,” said Elaine Belansky, PhD, RMPRC director and co-principal investigator of the Working to Improve School Health and the Healthy Eaters, Lifelong Movers (HELM) projects. “We’ve been focused on the obesity-prevention side of things, which is really important and a significant issue in rural Colorado, but so is emotional well-being.”

Longer reach, broader focus

Health project serves rural Colorado schools
The current RMPRC project encompasses 27 school districts in rural Colorado.

In HELM’s first three years alone, moderate to vigorous activity levels in elementary school PE classes increased by 66 percent, and nearly 100 evidence-based environment and policy changes to combat childhood obesity were implemented in the southern Colorado study area. The current project, which encompasses 27 school districts, now will align with the Whole School, Whole Community, Whole Child (WSCC) model.

WSCC’s holistic focus with attention to 10 components, ranging from physical education and physical activity to counseling and social services, could have a dramatic effect in the region, Belansky said.

“We’ve heard from so many principals and superintendents that their No. 1 concern about students is their mental health,” said Belansky, adding that the region’s high poverty levels bring stressors that can sabotage children’s learning. In the largely agricultural San Luis Valley, an area the size of New Jersey with a population so sparse it could not fill Mile High Stadium, health-care resources are also stretched thin.

Benjamin Ingman
Benjamin Ingman, PhD, principal investigator of AIM-XL.

“There is a lot of need there,” said Benjamin Ingman, PhD, principal investigator of AIM-XL. “Being able to bring this focus to the kids’ well-being is really important. Kids need to feel safe and be well-fed before they can start thinking about being successful and happy in school. I hope that this program will help these schools focus on some of these baseline concerns.”

Happy kids, better learners

During her years focused on southern Colorado’s rural areas, Belansky has heard many heart-wrenching stories related to hunger, parents in prison, family addictions and poor living conditions, all matters that make focusing on school difficult for students and place huge burdens on teachers and administrators.

The RMPRC, with the help of project manager Shannon Allen, PhD, and others, aims to ease those burdens by helping school districts bring all players  ̶  including community agencies, staff,

teachers, parents, administrators and students  ̶  to the table to build programs and partnerships that support students’ overall well-being. Ingman, who wrote the recent grant proposal, said he hopes lessons learned from the team’s work eventually will reach beyond rural boundaries and influence other schools to broaden their educational aims.

None of the work would be possible without Ingman’s dedication, TCHF’s funding, and the support of school districts in the San Luis Valley and southeastern Colorado, Belansky said. “I’m so proud that we have somebody who understands schools and how important it is to focus on the health and happiness of the child, not just academic achievement,” she said of Ingman. “And I’m really proud that all of these districts in rural Colorado value working on the WSCC model to make a child’s educational experience a richer one.”

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TBI laws effective in reducing concussions among high school athletes

A new study using data collected in a national sports injury surveillance system by researchers at the Colorado School of Public Health at the University of Colorado Anschutz Medical Campus has found that state-level TBI laws are, in fact, beneficial in reducing the rates of new and recurrent concussions among U.S. high school athletes. Between 2009 and 2014, all 50 states and the District of Columbia enacted one or more traumatic brain injury (TBI) laws, more commonly known as concussion laws. These laws often include mandates to remove athletes from play following an actual or suspected concussion, a medical clearance before they can return to play, and annual education of coaches, parents, and athletes regarding concussion signs or symptoms.

The study, led by Dr. Ginger Yang at the Center for Injury Research and Policy at Nationwide Children’s Hospital with researchers from the Colorado School of Public Health and Temple University, is published in the November 2017 edition of the American Journal of Public Health. The study found that rates of new and recurrent concussions initially increase after a law goes into effect due to mandated reporting, but this is also likely due to greater awareness of the signs and symptoms of concussion itself. The authors also indicated that approximately 2 ½ years after a TBI law is in place, the data indicated that rates of recurrent concussions resulted in a significant decline.

“These concussion laws follow in a long-line of successful legislation efforts in public health injury prevention,” said Dawn Comstock, PhD, principal investigator of High School RIOTM  (Reporting Information Online), the national surveillance database that tracks high school sport injuries at the Colorado School of Public Health. “These laws in particular were passed quickly and are truly effective as found in the data and this study. What is even more interesting is even though there isn’t an enforcement of these laws—people wouldn’t be ticketed like they might be with speeding or not using their seatbelt, these laws did make a difference. It is a great example of how legislative efforts can actually drive public health and injury prevention.”

This study looked at TBIs in high school athletes who competed in at least one of nine sports between 2005 and 2016. The high school sports included boys football, boys wrestling, girls volleyball, boys and girls soccer, boys and girls basketball, boys baseball, and girls softball. Over 11 years, there were an estimated 2.7 million reported concussions in high school athletes engaged in these sports, which translates to an average of 671 concussions per day, or about one concussion in a high school athlete every two minutes. Of the reported concussions, approximately 89 percent were new while 11 percent were recurrent (a repeat concussion in an athlete that has already had at least one other concussion).

The data also showed that concussions were more frequent among male athletes, particularly in football, and during competitions. Football had the highest average annual concussion rate, followed by girls’ soccer and boys’ wrestling. Overall, males have a higher average annual concussion rate than females, but when comparing the rates in gender comparable/available sports (basketball, soccer, baseball/softball), females had almost double the annual rate of concussions as males.

This study was funded by a grant from the Robert Wood Johnson Foundation’s Public Health Law Research program. State-level concussion law data was obtained from LawAtlas. Concussion data was collected from High School RIOTM  (Reporting Information Online), a prospective, longitudinal internet-based surveillance system housed in the Program for Injury Prevention, Education and Research at the Colorado School of Public Health that collects sport-related injuries and exposures among athletes from athletic trainers at a nationally representative sample of U.S. high schools.

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Alumni earn prestigious science policy fellowships

Two University of Colorado Denver | Anschutz Medical Campus alumni have earned prestigious AAAS Science & Technology Policy Fellowships. They are among the latest class of policy fellows – 280 scientists and engineers – who will spend a year serving professionally in federal agencies and congressional offices.

Mark Lucera and Juliette Petersen won the fellowships, which are operated as part of the American Association for the Advancement of Science (AAAS) mandate to “advance science and serve society.” Petersen graduated in December 2016 with her PhD from the CU Anschutz Molecular Biology Program, while Lucera is a CU Anschutz postdoc and finished his doctoral work in the Molecular Virology program at Case Western Reserve University in January 2016.

Application deadline

The application deadline for the 2018-19 AAAS Science & Technology Policy Fellowship class is fast approaching – Nov. 1. For more information about the fellowships, visit the AAAS website. Information is also available through the Postdoctoral & Career Development Office in the CU Denver | Anschutz Graduate School.

Since the program’s inception in 1973, over 3,600 AAAS fellows have supported congressional offices, executive branch agencies and departments and the judicial branch, seeding virtually every corner of Washington, D.C., and beyond with a high caliber of scientific know-how.

Following is a Q&A with Lucera and Petersen about how they became interested in the AAAS Fellowship, how their training at CU Anschutz prepared them for the program, and what they’re hoping to achieve in their career. 

Juliette Petersen

When did you get interested in this program?

I first got interested in the AAAS STPF in 2006 when I was volunteering on Bill Ritter’s gubernatorial campaign in Colorado. I had left a doctoral program in synthetic organic chemistry in 2005, but I knew that science was in my blood. During the campaign I was discovering a love of policy, too. At one of the campaign planning meetings, I met a PhD scientist who was working as a science advisor to someone at the national level, and he told me about AAAS STPF. I don’t even remember his name or who he worked for, but I went home and started researching the fellowship program and realized that it was exactly what I was looking for – an opportunity to meld my love of science with my desire to be involved in policymaking. With that in mind, I went back for my PhD in molecular biology (which I found much more gratifying than organic chemistry!) and the rest is history!

What are you hoping to do career-wise?

CU Anschutz graduate Juliette Petersen
Juliette Petersen

The crazy thing is that after working toward this fellowship for over 10 years, I never planned beyond the fellowship. Actually, it’s not as crazy as it sounds – everyone who has been a Fellow talks about how the experience is life-changing, and how you will meet so many people and open doors through the fellowship that you didn’t even know existed. I know that I have a strong interest in global health and I would like to explore that and food sustainability during my fellowship. After that? Well, I know I want to continue to work at the intersection of science and policymaking and to continue to bring scientific thinking into the policymaking conversation.

How did your training at CU Denver / Anschutz prepare you for this program?

Honestly, it was mostly my activities outside of my “training” at CU Anschutz that prepared me for this program, though of course you need to have a solid scientific training in order to bring scientific reasoning and thinking to the table. I was active in the Careers in Science Club (www.careersinscienceclub.com) for almost all of my time at CU Anschutz, including when we were asked to change the name from “Alternatives in Science” to something that more closely reflected the fact that non-academia career tracks are no longer “alternative.” I participated in various CU Advocacy Days at the State Capitol, and got involved in additional advocacy through the March of Dimes. I participated in as many outreach opportunities as I could, including Young Hands in Science, which brought real scientists into elementary schools to teach various science modules. I also took advantage of numerous opportunities offered by the NIH BEST grant. Basically, I did as many “extracurricular” activities as I possibly could without sacrificing my lab work.

What advice would you have for others who might want to consider this path?

Get out of the lab. Seriously. What are you passionate about? Start a club or get involved in a pre-existing one. Seek out leadership opportunities. Take advantage of the numerous outreach opportunities available through CU Anschutz or find/create your own. I know you don’t have a lot of free time in grad school, but it’s worth it for your sanity to have something outside of lab. No matter what career path you choose, you need to work on communicating clearly and concisely (without science jargon), so you might want to start thinking about that, too. You don’t have to be doing advocacy or policymaking – the Fellowship will provide you with numerous professional development opportunities to build those skills – but you DO need to be involved in something beyond your own research.  

Mark Lucera

When did you get interested in this program?

I first learned about the AAAS Science and Technology Policy Fellowship while I was a PhD student in the Molecular Virology program at Case Western Reserve University. I was in a “career exploration” phase toward the end of my training and I saw the AAAS fellowship as a unique opportunity to combine my interests. I almost applied back then but decided instead to expand my expertise in a postdoctoral fellowship. I wanted to learn from a mentor whose role as a physician lends strong appreciation for public health, so I chose to come to CU Anschutz to train within the Division of Infectious Diseases in the Department of Medicine. My experience as a postdoc taught me a number of skills but it also reignited my drive to apply for the AAAS fellowship.

What are you hoping to do careerwise?

CU Anschutz postdoc Mark Lucera
Mark Lucera

I thrive when I’m given opportunities to communicate, so combining my passion for science in a policy setting is a really good fit.  My training up to this point has largely been studying infectious diseases like HIV/AIDS in the laboratory. As an AAAS fellow, I’ll be approaching my field from a different perspective, working on international health and biodefense policy. I can see myself staying in the global health realm after my fellowship, whether in government, specialized agency or NGO.

How did your training at CU Denver / Anschutz prepare you for this program?

My postdoc helped me in a number of ways. In the lab, I continued research on HIV/AIDS while also branching out to study additional viruses.  I also had the opportunity to collaborate with global health folks studying disease burden in Central America. This was shortly after the wave of Zika virus, and being involved gave me a newfound appreciation for the international relationships required to combat epidemics.

Outside of the lab, I was very active in our Postdoctoral Association. I chaired of our Engagement Committee, tasked with developing programs that enriched social and professional relationships amongst postdocs.  I also helped start a scientific advocacy initiative called Project Bridge and gained direct experience building relationships with Colorado policymakers and our local community. I can’t emphasize enough the importance of these leadership roles in growing my communication skills. They’ve also been a lot of fun and I’m really grateful.

What advice would you have for others who might want to consider this path?

Two things.  First, invest time in assembling your “professional development toolbox”. Build your communication skills, get involved with advocacy or outreach, practice writing to diverse audiences, participate in the Postdoctoral Association. Your technical expertise will be a strong engine, but these other skills will actually allow you to drive the car.

Second, remain flexible. The AAAS fellowship attracts folks from many backgrounds, and placement opportunities are just as diverse. The common thread is that we’re all expert problem solvers. While I’m staying roughly in the same field, there are fellows who use this experience to explore new areas at the intersection of science and policy.

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Researchers say climate change may accelerate infectious disease outbreaks

Aside from inflicting devastating natural disasters on often vulnerable communities, climate change can also spur outbreaks of infectious diseases like Zika , malaria and dengue fever, according to a new study by researchers at the University of  Colorado Anschutz Medical Campus.

“Climate change presents complex and wide-reaching threats to human health,” said Cecilia Sorensen, MD, lead author of the study and the Living Closer Foundation Fellow in Climate and Health Policy at CU Anschutz. “It can amplify and unmask ecological and socio-political weaknesses and increase the risk of adverse health outcomes in socially vulnerable regions.”

When natural disasters strike such places, she said, the climatic conditions may make the public health crisis significantly worse.

Dr. Cecilia Sorensen, lead author of the study and the Living Closer Foundation Fellow in Climate and Health Policy at CU Anschutz.
Dr. Cecilia Sorensen, lead author of the study and the Living Closer Foundation Fellow in Climate and Health Policy at CU Anschutz.

The researchers said these vulnerabilities can happen anywhere. After Hurricane Katrina hit New Orleans, cases of West Nile disease doubled the next year. Climate change in Africa appears to be increasing cases of malaria. And the recent destruction in Houston, Florida and Puerto Rico due to hurricanes may usher in more infectious diseases in the years ahead.

The study focused specifically on a magnitude 7.7 earthquake that struck coastal Ecuador in April 2016, coinciding with an exceptionally strong El Niño event. El Niños are associated with heavy rainfall and warmer air temperatures. They are also linked to outbreaks of dengue fever.

Sorensen, a clinical instructor in emergency medicine at CU Anschutz, was in Ecuador with her co-authors working with the Walking Palms Global Initiative. They were operating a mobile health clinic after the disaster.

“We were seeing all of these viral symptoms in the wake of the quake,” she said. “We noticed a huge spike in Zika cases where the earthquake occurred. Prior to this, there were only a handful of Zika cases in the whole country.”

In fact, the researchers found the number of Zika cases had increased 12-fold in the quake zone.

Zika virus is transmitted by mosquitos. Symptoms are usually mild but the infection can cause major abnormalities and even death in a developing fetus.

Warmer temperatures and increased rainfall from the El Niño, along with a devastated infrastructure and an influx of people into larger cities, likely caused the spike in Zika cases, Sorensen said.

Natural disasters like Hurricane Katrina can spur outbreaks of infectious disease.
Natural disasters like Hurricane Katrina can spur outbreaks of infectious disease.

“We saw so many people affected by the earthquake that were sleeping outside without any shelter from mosquitoes, so we were worrying that the region’s changing climate could facilitate the spread of diseases,” she said. “Natural disasters can create a niche for emerging diseases to come out and affect more people.”

Sorensen’s team reviewed the existing research on the link between short-term climate changes and disease transmission. They applied those findings to explain the role of the earthquake and El Niño in the Zika outbreak.

They suggest El Niño created ideal conditions for Zika-carrying mosquitos to breed and make more copies of the Zika virus. The warmer temperatures and increased rainfall from El Niño have previously been associated with a higher likelihood of dengue outbreaks. Warmer temperatures can also accelerate viral replication in mosquitoes and influence mosquitos’ development and breeding habits.

At the same time, the El Niño event brought warmer sea-surface temperatures, which have been shown to correlate with outbreaks of mosquito-transmitted diseases. Estimates from remote sensing data in coastal Ecuador show that sea-surface temperatures were higher than average from 2014-2016.

The team also believes an increase in water scarcity after the earthquake indirectly benefited mosquito development. The quake damaged municipal water systems, forcing people to store water in open containers outside their homes. These served as additional habitats for mosquito larvae.

The new findings could be used by governments to identify and protect vulnerable communities before natural disasters happen, Sorensen said.

“One idea is to develop disease models that can use existing climate models to predict where these vectors will show up due to climate variability,” she said. “Applying these new models to areas that have pre-existing social vulnerabilities could identify susceptible regions, allowing us to direct healthcare resources there ahead of time.”

The study was published October 12 in GeoHealth, a publication of the American Geophysical Union.

The co-authors of the study from CU Anschutz include Emilie Calvello-Hynes, MD, assistant professor of emergency medicine and Jay Lemery, MD, associate professor of emergency medicine and chief of wilderness and environmental medicine.

The other co-authors include: Mercy J. Borbor-Cordova, Faculty of Naval Engineering, Oceanic Sciences and Natural Resources, Escuela Superior Politecnica del Litoral, Guayaquil, Ecuador; Avriel Diaz, Dept. of Evolution, Ecology and Environmental Biology, Columbia University; Anna M. Stewart-Ibarra, Department of Public Health and Preventative Medicine, SUNY Upstate Medical University, Syracuse, NY.

This paper is a collaboration of the University of Colorado Consortium for Climate Change and Health.

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New oral diabetes drug shows promise

A University of Colorado Anschutz Medical Campus study finds sotagliflozin helps control glucose and reduces the need for insulin in patients with type 1 diabetes.

Principal results were published today in the New England Journal of Medicine of a global Phase 3 clinical trial in patients with type 1 diabetes treated with sotagliflozin. Sotagliflozin is an investigational new oral drug for patients with type 1 diabetes that has shown promise in improving glucose control without any increase in severe hypoglycemia or diabetic ketoacidosis compared to insulin alone.

Garg
Dr. Satish Garg

Among 1,402 trial participants given the drug, sotagliflozin showed clinically meaningful and statistically significant effects on glucose control. Concentrations of hemoglobin A1C, a measure of plasma glucose, were improved. Patients experienced a lower rate of confirmed severe hypoglycemia than observed in patients on placebo and also had weight loss.

According to lead investigator Satish Garg, MD, professor of medicine and pediatrics at the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus, no oral medication has ever been approved for the treatment of type 1 diabetes and sotagliflozin has the potential to become the first new treatment innovation in nearly a century since insulin.

Most patients do not achieve optimal glycemic control with insulin alone. A1C concentrations, hypertension and reduction in body weight are critical issues which significantly impact people living with type 1 diabetes.

“If approved by the FDA, sotagliflozin may be the first oral drug that helps patients with type 1 diabetes in improving their glucose control without any weight gain or increase and severe hypoglycemia,” Garg said. “If long-term use continues to show similar metabolic improvements in patients with type 1 diabetes, it is likely that the long-term complications of diabetes would be significantly reduced.”

Sotagliflozin would be used in conjunction with insulin. Trial participants taking the drug as an oral pill alongside traditional insulin treatments experienced significant improvements in glucose control, a drop in systolic and diastolic blood pressure and weight loss.

Sotagliflozin is a unique dual inhibitor that works by inhibiting two sodium-glucose transporters: SGLT1 and SGLT2. Each modulates glucose levels. SGLT1 regulates the uptake of glucose in the gut while SGLT2 regulates the re-uptake of glucose in the kidney, according to the authors.

“Sotagliflozin added to insulin therapy can potentially help patients with type 1 diabetes improve their glucose control and hopefully manage the disease with fewer complications,” Garg said. “This would not be a replacement for insulin; it is an adjunctive therapy. However, because it works in the gut and the kidneys, it doesn’t require insulin to have an effect.”

The inTandem3 study was a double-blind, placebo controlled and randomized Phase 3 trial including adults with type 1 diabetes at 133 sites worldwide. In conjunction with this publication, the data were announced today at the 53rd Annual Meeting of the European Association Study for Diabetes in Lisbon, Portugal.

The 24-week trial evaluated the safety and efficacy of sotagliflozin at 400mg per day in randomized patients treated with any insulin regimen – pumps or injections. Eligible patients included men and nonpregnant women aged 18 and older, and they were required to self-monitor blood glucose.

The study met its primary endpoint with statistical significance, demonstrating the superiority of sotagliflozin 400 mg compared to placebo in the proportion of patients with A1C less than seven percent at week 24, no episode of severe hypoglycemia and no episode of diabetic ketoacidosis after randomization.

The outcome on every secondary endpoint favored sotagliflozin over placebo, achieving statistical significance for all four secondary endpoints, including change from baseline in A1C, body weight, systolic blood pressure in patients with baseline SBP less than or equal to 130 mm Hg and bolus insulin dose. Sotagliflozin significantly reduced A1C compared to placebo after 24 weeks of treatment.

“As is known with sodium glucose cotransporter 2 (SGLT2) inhibitors, patients experienced more episodes of diabetic ketoacidosis in the trial,” Garg said.

Diarrhea and genital mycotic infection also affected participants more than placebo, but less than one percent discontinued the study due to these effects.

“Sotagliflozin may reduce the bad effects of insulin and the dose patients need,” Garg said. “Patients in our study had lower weights, no severe hypoglycemia and better blood pressure.”

Garg is a faculty member at the University of Colorado School of Medicine at the Anschutz Medical Campus and is editor in-chief of Diabetes Technology and Therapeutics Journal.

Garg and his colleagues are working to publish more results on other inTendem1 and 2 phase 3 clinical trials in type 1 diabetes, including data on continuous glucose monitoring in future publications.

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Jankowski awarded NIH funding for bone density study

Approximately 46 percent (21 million) of older women in the United States have low bone mass, a condition that increases the risk of fracture, disability, and death, but may also be reversible. Exercise is recommended to maintain bone health in women, but the benefits of exercise may be limited by low levels of sex hormones after menopause.

Kathy Jankowski of CU College of Nursing
Kathy Jankowski, PhD, FACSM

A new R01 (a type of research project funded by the National Institutes of Health) study, “DHEA Augmentation of Musculoskeletal Adaptations to Exercise in Older Women,” led by CU College of Nursing Associate Professor Kathy Jankowski, PhD, FACSM, will attempt to show whether dehydroepiandrosterone (DHEA) will provide estrogenic and androgenic hormonal responses that will enhance the benefits of exercise on bone and muscle in postmenopausal women.

High-impact research

“This research has high impact and importance for women, who have a longer life expectancy than men, and are more prone to health issues arising from lower bone mineral density,” Jankowski says. The project is federally funded for a five-year period of study at $600,000 per year.

Exercise is recommended for postmenopausal women to maintain or increase areal bone mineral density, to improve muscular fitness and balance, and ultimately to prevent fractures. During exercise, joint-reaction and ground-reaction forces contribute to strain signals that are transduced via a mechanostat to osteocytes, causing region-specific adaptations in bone tissue.

However, age-related declines in anabolic adrenal, gonadal, and somatotropic hormones may blunt this and other musculoskeletal adaptations. DHEA is the major source of estrogen and testosterone in postmenopausal women, but adrenal DHEA production declines with age.

Jankowski’s research project proposes that DHEA therapy, by providing androgenic and estrogenic hormonal support, will augment the effects of bone-loading exercise on areal bone mineral density and fat free mass in women with low areal bone mineral density (i.e., osteopenia). This population is the focus because low area bone mineral density, an indicator of fracture risk, could be corrected with hormonal treatment.

Measuring changes to bone architecture

“There only a few anabolic hormonal therapies approved to increase bone density in women, and these are typically prescribed only for women with osteoporosis,” Jankowski says. “DHEA has the advantage of providing anabolic effects on bone, and is well-tolerated in postmenopausal women. Exercise is the only therapy that provides benefits to muscle and bone. I am looking forward to discovering whether combining exercise with DHEA provides benefits to muscle and bone that exceed that of either DHEA or exercise alone.”

Jankowski’s study will measure changes in bone architecture in addition to bone density. “Small changes in bone architecture can have profound effects on bone strength,” she says. “It is currently not known if DHEA has beneficial effects on bone architecture.”

To learn more about research projects at the CU College of Nursing Office of Research and Scholarship, contact CON.ORS@ucdenver.edu .

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Doping in sports: official tests fail to pick up majority of cases

Doping is remarkably widespread among elite athletes and remains largely unchecked despite the use of sophisticated biological testing methods. This is according to Rolf Ulrich of the University of Tübingen in Germany and Dawn Comstock of the Colorado School of Public Health at the University of Colorado Anschutz Medical Campus. They are lead authors of a study in Springer’s journal Sports Medicine.

The researchers conducted anonymous surveys among athletes competing at two major sports events in 2011. At least 30-45% of athletes at these events acknowledged that they had used banned doping substances or methods in the previous year. This is a serious concern because doping not only compromises fair play, but it is potentially detrimental to the health of athletes.

Biological tests of blood and urine typically detect doping in only 1-3% of competitors at elite international competitions. However, the new study suggests that the true rate of doping is far greater, because cutting-edge doping schemes seem to make it possible for many athletes to beat the biological tests currently in place to detect prohibited doping.

“Given the numerous recent highly publicized doping scandals in major sports, one might guess that the proportion of such undetected cheats is high,” write Ulrich and his coauthors. In their paper, the authors cite several recent commentaries suggesting that technical, human, political and financial factors are all contributing to flawed results from current biological testing techniques.

The research team conducted anonymous tablet-based surveys of the prevalence of doping at two major sports events in 2011. These were the 13th International Association of Athletics Federations World Championships in Athletics (WCA) in South Korea and the 12th Quadrennial Pan-Arab Games (PAG) in Qatar. The surveys used a randomized response technique, a method that visibly guaranteed the anonymity of the respondent, thus permitting the athletes to answer honestly about their doping without fear of exposure. Surveys were completed by 2167 athletes at the two events.

Even after assessing statistically for various possible forms of bias in the results, the authors estimated that at least 30% of athletes at WCA and 45% of athletes at PAG had engaged in doping during the previous year. The statistical analyses suggested that, if anything, these figures may well have underestimated the true prevalence of doping at the two events. By contrast, on biological testing at WCA, only two (0.5%) of the 440 athletes tested positive for illegal substances. At PAG, 24 (3.6%) of the 670 athletes tested showed positive results.

“These findings suggest that biological testing greatly underestimates the true prevalence of doping in elite athletics,” Dawn Comstock, professor of epidemiology at the Colorado School of Public Health at CU Anschutz, said. “It indicates the need for future studies of the prevalence of doping in athletics using randomized response techniques to protect the anonymity of the athletes.”

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