Following the people and events that make up the research community at Duke

Category: Medicine Page 1 of 18

The Diversity Problem in Science

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With COVID-19 being a fixture of our lives for nearly a year now, science has been a staple in the news. Along with science, though, a long-overdue conversation about the state of race relations in America has taken center stage, which makes diversity in science a critical topic to delve into. COVID-19 has highlighted not only a national crisis in healthcare response, but also longstanding health disparities across racial and socioeconomic groups that have only been exacerbated by the pandemic.

 On Wednesday, January 27, Dr. Gowthami “Gow” Arepally, known for her work as Professor of Hematology at the Duke School of Medicine, led a talk called “The Diversity Problem in Science” that aimed to highlight not only the obvious problems in research but the urgency with which everyone, from the individual to the collective level, should aim to address the problem within their spheres of influence. Dr. Arepally is not only known for her work in the medical school but also as a valuable mentor for colleagues, undergraduates, and high school students — a point that was highlighted as an important way non-URM (under-represented minority) scientists can make a difference.

Gowthami Arepally, M.D. 

Underrepresentation in science starts early, Arepally says. For example, while discrepancies in graduation rates between Black/Hispanic students and their white/Asian peers are not bad in high school, they get progressively worse through college and beyond. In 2016, 18% of degrees nationally were awarded overall in STEM fields — but this number drops to 12% for Black students and 15% for Hispanic students. As of 2015, Black applicants have lower medical school acceptance rates than peer applicants – 34% versus 44% for their white counterparts. And the numbers get worse further into medical school; Black students and Hispanic students each represent less than 6% of medical school graduates, while a staggering 80% of graduates are either white or Asian.

This perpetuates a cycle going into the workforce that discourages young underrepresented minority (URM) students from entering STEM, seeing a lack of role models that look like them. As of 2016, only 39% of full-time faculty at medical schools were female, and a mere 4% of faculty were Black. This results in barriers to NIH research that further hold URM scientists back. Between 1999 and 2012, 72% of NIH awards were given to white scientists and 24% were given to Asian scientists, but only 2.4% of these awards were given to Black scientists.

This is a story that is shocking when told through statistics but is all too familiar, as an experience, for minority students and researchers interested in pursuing careers in the sciences. However, there are concrete ways to counter the problem. As Dr. Arepally pointed out, NIH Diversity Supplements for existing NIH grants can be obtained from the high school to faculty level as an added source of support for URM researchers. Medical societies themselves can be sources of diversity initiatives, such as Dr. Arepally’s society, the American Society of Hematology, which boasts one of the most aggressive minority recruitment initiatives. Within Duke, many pipeline programs exist for researchers to support URM students and new researchers and faculty.

Chart of pipeline programs at Duke

Most importantly, it’s important for individuals to enact change on a personal level. Whether it means educating oneself on underrepresentation, advocating for the advancement of other URM trainees and colleagues, or committing to the success of URM students through pipeline programs, individual steps can add up.

And as Dr. Arepally highlighted, these steps, however small, are important to prioritize. Increasing diversity in medicine, for example, can help address existing health disparities. URM physicians are more likely to address the care of minority populations, while minority patients are more likely to choose URM populations. And the existence of more URM physicians improves the cultural competency of all trainees. Sex diversity, too, has a positive effect on the quality of science in collaborative groups. The impacts of diversity extend to role-modeling for younger students, who may be at a crossroads in terms of determining a future career. In this way, current measures to increase diversity can foster a cycle of more diverse students entering STEM and being supported there, for generations to come.

Diversity in science is not only good for science and scientists, Arepally says, but for all of us. Science should reflect the society it serves, and with more diversity in science, breakthroughs will be applicable and accessible to every person —  not just the majority.

Post by Meghna Datta

Physician-Scientist Takes the Long View and Sets Her Sights High

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Dr. Bryan Batch, a Duke endocrinologist and researcher, studies treating metabolic disorders (like diabetes) with non-pharmacological approaches. But, she says, her parents’ medical professions, and the hard work that went into them, resulted in her not wanting to pursue science at all as a child.

Bryan Batch MD

When she took biology in middle school however, it clicked. It didn’t feel like “the slog of math,” she says, because she enjoyed studying life in its different forms. This infatuation with science combined with a love for other people pushed her to pursue medicine.

Now, Dr. Batch focuses on racial disparities. She says that a huge issue with disparities, whether they involve race, poverty, food insecurity, educational opportunity, or health insurance, is that they are often driven by policy. “We are not trained to know how to affect change in policy in medical school — it’s not something we are taught. But I do think if physicians got more involved in politics and policy we would be able to make significant positive impact.”

What she does try to do is adapt to individual patient needs in the moment. Her work at Duke signifies what she, as a healthcare provider, can do within the time spent with patients to interact in the best way possible. For example, she can understand if someone has a literacy issue and adapt her methods of explanation so that their literacy doesn’t hinder their understanding. While it can be challenging for one person to change systemic issues or share lived experiences with people of different backgrounds, Dr. Batch makes every effort to create a comfortable environment where she is able to leave a positive impact.

These impacts have no doubt been affected by COVID-19, which Dr. Batch describes as one of the most challenging experiences in her twenty years of practicing medicine. Although telephone and video conferencing have been available for years, Dr. Batch explains that only now is there a drive to put them to use. “It was like someone came up behind you and just whacked you on the head,” she says — no warning, no time to get organized.

Dr. Batch feels lucky to be in endocrinology, where there is flexibility for remote visits. Yet, even when patients do have the chance to have an in-person visit, some don’t want to. If they do, the physical separation, masks, and face shields create a feeling of distance. Dr. Batch spends much of her clinical time at the Durham Veteran Affairs Hospital, across the street from Duke Hospital, where many hearing-impaired patients have difficulty understanding her words because her mask takes away the ability to read lips.

Dr. Batch says that even after the pandemic has passed, more than 30% of visits may remain over the telephone, which can give patients increased access to their doctors.

The challenges have infiltrated her research too, where now the only people she can bring in are those who need to visit the VA Medical Center for another reason anyway, like going to the eye doctor. Overall, she says, she has been surrounded by phenomenal people who rolled up their sleeves and said “let’s get it done.” Still, it has been exhausting.

The Durham Veterans Administration Medical Center, where Dr. Batch conducts most of her practice.

To her, family is everything, and she tries her best to stay in touch with the people who matter most as a way to get through it all.

Even before COVID-19, Dr. Batch has been intentional about living her life to the fullest and staying true to her core values. If that means rescheduling things at work to be with her kids, she is unapologetic. She chose endocrinology as a specialty in part because it’s very family-oriented, and she feels lucky to have colleagues who understand the flexibility she values. Her ultimate goal is to leave a mark on the world but she also wants her happiness to come from what matters, so she stays close to her big family and lots of friends.

While sacrifices are inevitable in any career, Dr. Batch tries not to make large ones on the homefront. She takes it day by day, week by week, she says, to make it such that “work” and “life” are in harmony as much as possible. It is easy to get caught up and have the years go by, one day realizing that the important people have pulled away.  Dr. Batch is deliberate about making the time for these people, including her two children and husband.

Dr. Batch is a role model for young people, particularly for women of color. She shared an anecdote about her inattentive high school counselor, to whom she went for a signature on her college application list. Seeing Yale, Harvard, and Brown, he told her that she was “reaching too high.” Batch responded, “I’m not here for your opinion on this list. I’m here for you to sign this form..

She ended up at Yale.

She says she had the courage to talk back to the counselor  because her parents instilled the idea of working hard and pushing higher. What matters, she says, is believing in yourself and surrounding yourself with people who believe in you.

 Unfortunately, Batch said, underestimation by others resonated throughout her college, medical school, residency, and fellowship, because she is a woman or because she is Black.

At the end of the day, Dr. Bryan Batch never let other people define her experience but instead allowed her hard work to prove her value and propel her to always reach higher.

Guest Post by Viha Patel, Class of 2021, NC School of Science and Math

Claire Engstrom, a Student Researcher Working to Treat Duchenne’s Muscular Dystrophy by Optimizing CRISPr-cas9

Meet Claire Engstrom, a Senior from Pasadena California. Claire is a Biology major who works in the Gersbach Lab at Duke. 

Claire first got involved with on-campus research through her pre-orientation program, PSearch that introduces incoming first-years to undergraduate research. Following her experience in PSearch, Claire got her first work-study research position in the Tung Lab where she worked closely with Jenny Tung, an Associate Professor in the Departments of Evolutionary Anthropology and Biology at Duke and a Faculty Associate of the Duke University Population Research Institute. 

In the Tung Lab, Claire’s research focused on how DNA methylation is passed through generations. Essentially looking at the inheritance of DNA whose methylation was impacted by environmental factors and how that affects future generations. 

Duke has research opportunities available in all disciplines as well as across departments. Approximately 53% of undergraduates graduate with research experience. Not only can students participate in groundbreaking research, but they can receive funding from the university as well to support the work they are doing.

Within the Biology department, there is a fellowship called B-SURF, the Biological Sciences Undergraduate Research Fellowship, an 8-week summer research program for rising sophomores. Claire applied for and was accepted to the fellowship and placed in one of Duke’s biomedical science laboratories. She also received a $4,000 stipend for her summer research.

Claire was placed in Charles Gersbach’s Lab focused on researching Genome Editing for Gene and Cell Therapy. Dr, Gersbach is a Rooney Family Associate Professor of Biomedical Engineering and has conducted groundbreaking work in genome editing.

Members of the Gersbach Lab in Fall 2019

Gersbach is doing research in several different domains of biomedical engineering. Claire’s project focuses on using CRISPR-Cas9, a technology that allows scientists to change an organism’s DNA using clustered regularly interspaced short palindromic repeats and CRISPR-associated protein 9. faster, cheaper, more accurate, and more efficient than other existing genome editing methods. 

Prior to joining his lab, Claire had already heard a lot about Gersbach in her course Biology 201 as well as through reading his papers. The project she would spend the next two and a half years working on focused on using and optimizing CRISPR-Cas9 to treat Duchenne’s Muscular Dystrophy and lessen the severity of the symptoms. 

Duchenne’s Muscular Dystrophy is a muscle wasting disease that affects one in every five thousand male births.

“People are diagnosed when they are around five and then they lose the ability to walk and their heart can’t pump blood because of the lack of muscles.” Claire explained.  

“CRISPR-based genome editing restores dystrophin expression in mouse models of Duchenne muscular dystrophy. Cross-sections of muscle tissue where the dystrophin protein has been labeled green, including normal, healthy tissue (left), tissue from a mouse model of Duchenne muscular dystrophy (middle), and tissue from the same mouse model that has been treated with the CRISPR gene editing system (right). Nelson et al., Science (2016)”

Thus, those affected often die in early adulthood despite current advances in cardiovascular and respiratory treatments. Duchenne’s Muscular Dystrophy generally occurs as a result of a frameshift mutation of the dystrophin gene. As a result, one’s muscles can no longer connect to anything making it nearly impossible to contract and function properly. In the Gersbach lab they are trying to treat the mutation by using CRISPR-Cas9 to remove an exon or coding region of the gene in order to shift the reading frame back into its normal place. 

This shift produces a less severe phenotype that lessens the effects of Duchenne’s Muscular Dystrophy. The result will significantly improve the quality of life and life spans for affected patients. 

Claire will be continuing her work in the Gersbach lab full time in Spring 2021 as she graduated early, with distinction in the Fall. Her thesis on the work she did in the Gersbach lab was recently approved and her results will be published in a larger paper in the future. After this year she plans to take a gap year an then return to California to hopefully attend grad school and pursue a Ph.D. in Biology.

By Anna Gotskind

Widespread Vaccination Will Depend on Faith in Science

Two Covid vaccines have been approved via Emergency Use Authorizations. But, many scientists, health professionals, and regulatory members alike are left wondering how to best ensure the American and global public opt-in to getting vaccinated.

During Friday, December 18th Coronavirus Conversation hosted by the Duke Initiative for Science & Society, honored guests Anthony Fauci (M.D.) and Alan Alda discussed the restoration of faith in public science agencies, moderated by Hank Greely (J.D.). You can view the entire program here (40 min.)

Dr. Fauci has become a household name this year as a member of the White House Coronavirus Task Force but is more widely regarded as one of the most trusted U.S. medical figures and has been director of the National Institute of Allergy and Infectious Disease since 1984.

Mr. Alda, though popularized through his acting career, has been a life-long advocate for science. He hosted PBS show “Scientific American Frontiers,” founded the Alan Alda Center for Communicating Science at SUNY Stony Brook, and recently released a podcast titled “Soldiers of Science.” At Stanford, Mr. Greely is director for the Center for Law and Biosciences and the Program in Neuroscience and Society, as well as a Professor of Law.

Greely asked about the public’s current level of trust for science and what must be done to get it “where it should be.” Alda said that there “seems to be this awful fall off of trust in science … at the worst possible time.” But Dr. Fauci pointed out that we have seen the evolution of lack of trust in science over the previous couple of years. The pandemic fell in the middle of extreme American divisiveness, he said, leading to individuals “developing their own set of facts instead of interpreting [actual] data that exists.”

Alda and Fauci both emphasized the need for transparent and clear scientific communication as a main tactic for increasing public faith in science. This includes use of the words “I don’t know,” particularly in response to the question of vaccine longevity, a question Dr. Fauci said will be answered “in due time.”

Alda said scientific communicators should “communicate with audience[s] with respect … with personal contact where trust builds up more quickly.” He pointed out that this means communicators must become more familiar with their audiences, what terms would be best to use, and what their audiences are “ready to hear.” Dr. Fauci added that when someone is “speaking science” to any group, the objective should not be to “impress the [audience] as to how smart [they] are.” The two major objectives laid out by Fauci: 1) Know the audience and 2) know your message, avoiding granularity and inaccessible language.

Greely interjected that the though all three panelists agree on trust in science, they were three white guys “of mature years.” He continued to say that, “One of the saddest ironies [is that] people getting hammered hardest by [Covid] tend to be people from racial and ethnic minorities … those are also [the same] groups of people that have understandable historic reasons to have less trust [in scientific agencies].” How do we reach these groups?

To do this, Dr. Fauci proposed that we need to get messengers for vaccination to “to look like and understand to whom [we] we are delivering the message.” Leaning into an idea by Alda – that we should get celebrities and widely-respected and admired individuals to get vaccinated on television – Fauci described how Surgeon General Jerome Adams got publicly vaccinated Friday morning.

Adams also delivered a message to his “Black and Brown sisters and brothers” in support of vaccination. Dr. Fauci believes more positive messaging like this will be effective. Alda reinforced that “we can’t guess about the people we’re trying to talk to.” We have to know about their biases and cause for hesitancy in order to meet them where they are, as well as address their concerns in genuine, non-condescending ways.

Alda also proposed that individuals snap a quick shot of themselves getting vaccinated and post it to social media as a #vaccie – a play on the #selfie sensation – which Greely said was “brilliant.”

Alda and Fauci concurred that the most powerful proponents of restoring faith in science may lie in the impact of individual civilians who share their trust in and compliance with vaccination amongst family and friends. Fauci said individuals should not “underestimate the impact that they have in their own immediate environment.”

Sandra Lindsay, an Intensive Care Unit nurse in New York, was one of the first people in the U.S. to receive the Pfizer Covid vaccine.

This impact could be either positive or negative, though, as Alda pointed out the problem with social media algorithms. While working on “Soldiers of Science,” he learned that social media sites are designed to “keep your eyeballs on the screen” as long as possible. This means that social media sites keep “showing you what you want to see,” which is your own bias and affirmation that your ideas are correct. If #vaccie starts trending, this might provide necessary momentum for widescale vaccine uptake.

However, because we have become “addicted to [our] bias” and convinced “over and over again that only our view is right,” according to Alda, we must work intentionally to see commonalities across seemingly alienating lines. Reflecting on his work with AIDS, Dr. Fauci suggested that we take what scientific communicators and regulatory bodies learned during that time. “What do we all want?” Fauci said, ”And how do we get there in a way that is synergistic [instead of] opposing?”

In his parting thoughts, Alda stated simply that “science will save us.” It has and will continue to allow us to “counterattack the attacks we get from our mother nature.” Dr. Fauci said that in dealing with the current pandemic, “biomedical research and science has given us something that just a decade ago would have seemed unimaginable.”

“When this is over, and it’s going to be over,” Fauci said, “We’re [going to] look back and say, ‘It was science that got us out of this, pure science.’”

Greely said we have learned a lot about science communication this year – invaluable information that we must carry forward with us.

I, like so many others around the world, can’t wait for my turn to get the Covid vaccine and to kiss 2020 and the pandemic goodbye.

Post by Cydney Livingston

Contact Tracing Is a Call for Ingenuity and Innovation

The sudden need for contact-tracing technologies to address the Covid-19 pandemic is inspiring some miraculous human ingenuity.

Wednesday, December 16th, Rodney Jenkins, Praudman Jain, and Kartik Nayak discussed Covid-19 contact tracing and the role of new technologies in a forum organized by the Duke Mobile App Gateway team.

Jenkins is the Health Director of Durham County’s Department of Public Health, Jain is CEO and founder of Vibrent Health. And Nayak is an Assistant Professor in Duke’s Computer Science department. The panel was hosted by Leatrice Martin (M.B.A.), Senior Program Coordinator for Duke’s Mobile App Gateway with Duke’s Clinical and Translational Science Institute.

Contact tracing is critical to slowing the spread of Covid, and Jenkins says it’s not going away anytime soon. Jenkins, who only began his position with Durham County Public Health in January 2020, said Durham County’s contact tracing has been… interesting. As the virus approached Durham, “Durham County suffered a severe malware attack that really rendered platforms…useless.”

Eventually, though, the department developed its own method of tracing through trial and error. North Carolina’s Department of Health and Human Services (NC HHS), like many other health departments across the nation in March, was scrambling to adjust. NC HHS was not able to provide support for Durham’s contact tracing until July, when Jenkins identified a serious need for reinforcement due to disproportionate Covid cases amongst Latinx community members. In the meantime, Durham county received help from Duke’s Physician Assistant students and the Blue Cross Blue Shield Foundation. They expanded their team of five to 95 individuals investigating and tracing Durham County’s positive cases.

Rodney Jenkins MPH is the health director of the Durham County Public Health Department.

Jenkins proclaimed contact tracing as “sacred to public health” and a necessary element to “boxing in” Covid-19 – along with widespread testing.

Durham’s tracing tool is conducted through a HIPPA-compliant, secure online portal. Data about individuals is loaded into the system, transmitted to the contact tracing team, and then the team calls close contacts to enable a quick quarantine response. The department had to “make a huge jump very quickly,” said Jenkins. It was this speedy development and integration of new technology that has helped Durham County Public Health better manage the pandemic.

Jain, along with colleague Rachele Peterson, spoke about his company, Vibrent Health.  Vibrent, which was recently awarded a five-year grant from the National Institutes of Health’s ‘ll of Us Research Program, is focused on creating and dispersing digital and mobile platforms for public health.

Naturally, this includes a new focus on Covid. With renewed interest in and dependency on contact tracing, Jain says there is a need for different tools to help various stakeholders – from researchers to citizens to government.  He believes technology can “become the underlying infrastructure for accelerating science.”

Vibrent identified needs for a national tracing model, including the labor intensity of manual processes, disparate tools, and lack of automation.

Peterson said that as we “are all painfully aware,” the U.S. was not prepared for Covid, resulting in no national tracing solution. She offered that the success of tracing has been mostly due to efforts of “local heroes” like Jenkins. Through their five-year award, Vibrent is developing a next-generation tracing solution that they hope will better target infectious spread, optimize response time, reduce labor burden in managing spread, and increase public trust.

Along with an online digital interface, the company is partnering with Virginia Commonwealth University to work on a statistical modeling system. Peterson likened their idea to the Waze navigation app, which relies on users to add important, real-time data. They hope to offer a visualization tool to identify individuals in close contact with infected or high-risk persons and identify places or routes where users are at higher risk.

Nayak closed the panel by discussing his work on a project complementary to contact tracing, dubbed Poirot. Poirot will use aggregated private contact summary data. Because physical distancing is key to preventing Covid spread, Nayak said it is both important and difficult to measure physical interactions through contact events due to privacy concerns over sensitive data. Using Duke as the case study, Poirot will help decision makers answer questions about which buildings have the most contact events or which populations – faculty versus students – are at higher risk. The technology can also help individuals identify how many daily contacts they have or the safest time of day to visit a particular building.

Nayak said users will only be able to learn about their own contact events, as well as aggregate stats, while decision makers can only access aggregate statistics and have no ability to link data to individuals.

Users will log into a Duke server and then privately upload their data using a technology called blinded tokens. Contact events will be discovered with the help of continuously changing, random identifiers with data summation at intermittent intervals. Data processing will use multiparty computation and differential privacy to ensure information is delinked from individuals. The tool is expected for release in the spring.

Screenshot of Duke’s Mobile App Gateway site.

Although we are just starting vaccination, the need for nationwide resources “will be ongoing,” Martin said.

We should continue to embrace contact tracing because widespread vaccination will take time, Jenkins said.

Jenkins, Jain, and Nayak are but a few who have stepped up to respond innovatively to Covid. It becomes increasingly apparent that we will continue to need individuals like them, as well as their technological tools, to ease the burden of an overworked and unprepared health system as the pandemic prevails in America.

Post by Cydney Livingston

Most Highly Cited List Includes 37 from Duke

Five of the ten Duke women included in the most highly-cited list this year. Their scholarly publications are viewed as important and influential by their peers. (Clockwise from upper left: Costello, Curtis, Dawson, Bernhardt, Moffitt)

Duke’s leading scholars are once again prominently featured on the annual list of “Most Highly Cited Researchers.”

Thirty-seven Duke faculty were named to the list this year, based on the number of highly cited papers they produced over an 11-year period from January 2009 to December 2019.  Citation rate, as tracked by Clarivate’s Web of Science, is an approximate measure of a study’s influence and importance.

Barton Haynes

Two Duke researchers appear in two categories: Human Vaccine Institute Director Barton Haynes, and Michael Pencina, vice dean of data science and information technology in the School of Medicine.

And two of the Duke names listed are new faculty, recruited as part of the Science & Technology initiative: Edward Miao in Immunology and Sheng Yang He in Biology.

Michael Pencina

This year, 6,127 researchers from 60 countries are being recognized by the listing. The United States still dominates, with 41 percent of the names on the list, but China continues to grow its influence, with 12 percent of the names.

Clinical Medicine:

Robert M. Califf, Lesley H. Curtis, Pamela S. Douglas, Christopher Bull Granger, Adrian F. Hernandez, L. Kristen Newby, Erik Magnus Ohman, Manesh R. Patel, Michael J. Pencina, Eric D. Peterson.

Environment and Ecology:

Emily S. Bernhardt, Stuart L. Pimm, Mark R. Weisner.

Geosciences:

Drew T. Shindell

Immunology:

Barton F. Haynes, Edward A. Miao

Microbiology:

Barton F. Haynes

Plant and Animal Science:

Sheng Yang He

Psychiatry and Psychology:

Avshalom Caspi, E. Jane Costello, Renate M. Houts, Terrie E. Moffitt

Social Sciences:

Michael J. Pencina

Cross-Field:

Dan Ariely, Geraldine Dawson, Xinnian Dong, Charles A. Gersbach, Ru-Rong Ji, Robert J. Lefkowitz, Sarah H. Lisanby, Jie Liu, Jason W. Locasale, David B. Mitzi, Christopher B. Newgard, Ram Oren, David R. Smith, Avner Vengosh.

Phase 3 Trials: What We Know About a Covid Vaccine

As multiple drug companies in the United States speed towards Phase 3 trials for Covid-19 vaccinations, there remain many unanswered questions about these vaccines. 

Moderated by Professor of Law and Philosophy, Nita Farahany (J.D., Ph.D), principal investigators Cynthia Gay (M.D., M.P.H) and Emmanuel (Chip) Walter (M.D.) explored these lingering anxieties in a Science and Society hosted Coronavirus Conversation Thursday, November 6th. Dr. Gay is an Associate Professor of Medicine at the University of North Carolia Chapel Hill (UNC) and Medical Director of the UNC HIV Cure Center. Dr. Walter is a professor of Pediatrics with Duke’s Global Health Institute, as well as a member in the Duke Clinical Research Institute and Duke Human Vaccine Institute. Both Gay and Walter are currently overseeing trials for SARS-COV-2 vaccines. 

Farahany began the conversation by pointing out that though the previous ideal of a vaccine by the US presidential election did not come to fruition, Phizer and Moderna just reached full enrollment for their Phase 3 trials. “[The timeline question] is a million-dollar question,” said Dr. Gay, who is overseeing the Moderna trials at UNC. She said that soon statisticians who have no conflicts of interest with the trials will have a look at the unblinded trial data to see if there are any differences between those who received placebo injections and those who received vaccines. Gay believes this first “peek” may be too early to see a significant signal indicating success of the vaccines. Dr. Walter weighed in, saying that though he hopes “we’ll see something,” he concurs that Dr. Gay’s estimate that no significant signal will be present until January is an accurate one. 

As Gay and Walter explained, probed for clarification from Farahany, drug companies undertaking vaccine development enrolled portions of the population at higher risk for contracting Covid — typically on the basis of their form of employment. For example, someone working in healthcare statistically has a higher likelihood of contracting Covid because of increased exposure to environments where Covid-infected persons may be. Vaccine trial groups were either assigned to a placebo or to a vaccine. The drug companies will be able to test the success of the vaccines by evaluating whether those who received the vaccine contract Covid at some statistically significant lower amount than those who received the placebo. 

But as Farahany pointed out, a drug company could receive an Emergency Use Authorization (EUA) for their vaccine before trials are complete, prompting the question: Will Phase 3 trial placebo participants receive the vaccine if their company receives an EUA? Dr. Walter offered that this could be problematic because there would be a lack of long-term data on vaccines and Dr. Gay suggested that because blinding is the best sort of study design, there is tension around this question. However, Walter and Gay both agreed that study participants should be honored for the role they stepped into for these trials. Thus, the timing for the EUA may be the biggest determinant on whether or not placebo-receiving Phase 3 participants will receive the vaccines as soon as they are available or not.

Other concerns focus on the overall safety of the vaccines. All of the current Covid vaccines in development are mRNA vaccines, which have never before been approved for use in humans. Dr. Walter offered that before Covid, some companies were actually poised to start an mRNA vaccine in children for other respiratory pathogens and that mRNA vaccines are “pretty well studied.” Dr. Gay reinforced these notions by stating that she doesn’t have concerns about the vaccine safety, but rather whether or not the vaccines will actually work for the particular strand of virus and “produce enough effective antibodies to have an impact.” If Covid vaccines are successful, they may actually change the direction of vaccinology in a promising way.

Walter and Gay also addressed the concerns of side effects and generally conceded that most of the side effects seen, such as low-grade fevers and injection-site tenderness, are merely side effects seen with any sort of vaccine. As Farahany pointed out, these sorts of symptoms are actually often just a signal that the immune system is working and responding to the vaccine. Dr. Gay said that a lot of the concerns over vaccine side-effects can be thought about as cost-benefit analysis. She says we make these sorts of analyses all day, every day — whether we realize it or not. For Gay, one day of muscle soreness and a slight fever is highly preferential to weeks of potential immobilization from contracting Coronavirus. 

The concluding question: How do we ensure trials are met with public trust? “We have to remember we’re in the middle of a pandemic where things really have to move quickly,” Dr. Walter said. He also offered that though this has been the fastest vaccine development he’s ever seen – aside from H1N1 – all of the safety mechanisms in place have provided safety comparable to that we would normally see. 

“This is a global tragedy we’re dealing with,” Dr. Gay said. “There is a time to step back and think, ‘Isn’t it amazing that all these [amazing, talented, expert] people are working day and night’ …They’re making it happen to try to get us an answer and some effective vaccines.” 

Post by Cydney Livingston

Trust in Gynecology: The Impact of Race & Socioeconomic Status in Women’s Health

Nikki Mahendru’s mother didn’t go to the gynecologist for 45 years — and when she did, she regretted it. Ms. Mahendru felt “decades of anxieties and hesitancy reduced to five minutes of brisk interaction with her provider,” and left convinced that the “realm of women’s health was just not for her.” According to Nikki, a Duke University undergraduate, her mother’s “trust in the system was lost.” 

Mahendru joined Dr. Megan Huchko, the director of the Duke Center for Global Reproductive Health, and Dr. Chemtai Mungo, a Fogarty Global Health Fellow and OB-GYN doctor, on the Center for Global Women’s Health Technologies’ October 20 panel “Impact of Race and Socioeconomic Status in Women’s Health and Gynecology.” The panel was moderated by Ashley Deans and Alexandria Da Ponte.

Mahendru went on to detail an experience she had in the clinic with Carmen, a patient who spoke only Spanish and was also new to the gynecologist. The medical translator and Mahendru learned her story: she had been in pain for a year but had kept quiet due to money problems, had worked most of her life to send her kids to college, and was learning English via Rosetta Stone. With the details of Carmen’s story and an “equitable working relationship,” Mahendru and the translator could relay Carmen’s previous history to her provider. But Carmen’s provider knew only of her condition. 

Mahendru thinks gynecology done right has the potential to help women love their bodies and take care of their health, but gynecologists must earn the trust of their patients: “Acts of listening help bridge disparities.”

Dr. Huchko stated that throughout history, a male-dominated healthcare landscape saw the depiction of menses as ‘dirty,’ terms like ‘hysteria,’ and an overall lack of female control. The “father of gynecology” James Marion Sims exploited Black women in his development of the field, using unanesthetized slaves as subjects of experimentation. In general, Dr. Huchko sees a trend: “The lessening or decentering of women in women’s health corresponds to more discrimination.” In addition to the decentering of women, Dr. Huchko said that structural and individual factors “produce outcomes that prevent women from getting the care they need.” Like Mahendru, she identified trust as a central issue.

Dr. Megan Huchko, MD, MPH, is the director of the Duke Center for Global Reproductive Health

Dr. Huchko cited an experience in which she bore witness to the unattended consequences of racial bias in medicine. In Niger to repair women’s fistulas, which occur due to lack of postpartum care, Dr. Huchko felt she was attending to the downstream symptom of a much broader issue. She felt uncomfortable when the urogynecologist on her team ignorantly praised Sims without acknowledging his problematic history. Then, she saw this ignorance firsthand. 

Making a false assumption about the nature of the case, Dr. Huchko’s team chose to operate on a woman with a mass in her bladder. During the surgery, they realized the mass was a malignant tumor. With an unbiased eye and a complete exam and workup, this would have been clear. But because the team was looking at these women as “one-dimensional,” a woman with stage 4 cancer was subjected to a very invasive surgery that worsened her quality of life. 

Dr. Huchko experienced a similar lack of structural competency during her residency, where colleagues openly racially profiled people and overtly discussed disparities in pain tolerances among different ethnicities. Since then, “things have changed,” and she embraces this new culture of “being patient centered, exploring our own biases, and [having] zero tolerance for racial profiling.” She stresses the need for personal education and accountability alongside systemic change. Eventually, this will lead to women feeling “respected, seen, and heard.”

Coming to the US from Kenya, Dr. Mungo quickly came to appreciate the “sheer magnitude” of structural racism and its impact on health and healthcare. Dr. Mungo explained that “mutually reinforcing systems of disadvantage” for people of color, such as food deserts, are both the result and cause of healthcare disparities and result in enduring legacies of disadvantage.

Dr. Chemtai Mungo, MD, MPH, is a Fogarty Global Health Fellow and OB-GYN doctor

Dr. Mungo also observed that with healthcare in the US being so economically driven, the best care is often directed at those with racial and socioeconomic privilege. When she worked in a high resourced (read: white, wealthy) hospital, access to uterus-saving equipment such as interventional radiology meant that she only did one hysterectomy in four years. Doctors at the hospital also came in on weekends to get a person with cancer into the OR immediately.

Now, working at a “safety net hospital,” Dr. Mungo sees a stark difference. With non-existent interventional radiology and more part-time, “less invested” employees, Dr. Mungo has done three hysterectomies in three years — a 75% increase — and sees patients with time-sensitive conditions wait much longer before surgery. This “separate and unequal access to resources” is a cause for concern. 

Dr. Mungo also stressed the need to make practices “safe places” for patients of color by increasing minority representation. Dr. Mungo explained that while Black physicians make up only 5% of doctors and 3% of faculty, there is strong evidence that patients who are cared for by someone of their own race or ethnicity have better outcomes. “We live in a racist society,” Dr. Mungo stated, “so we need specific anti-racist policies.” 

Dr. Mungo also acknowledged that healthcare providers work within “templates” like 15 minute appointments, and posed the closing question, how can we make patients feel safe and heard within the constraints of modern medicine? 

Answering questions from the audience, Dr. Mungo and Huchko discussed medical algorithms that are based on race, like the VBAC calculator and GFR. 

Dr. Mungo indicted these algorithms as “an example of how institutionalized some [racial] biases are.” There is “no concrete evidence” on why these corrections for race — which typically act to reduce the probability of success for a procedure or favorability of an outcome — exist. Dr. Mungo would urge providers “not to stop at, ‘well, African Americans have an increased risk of diabetes.’ Ask why. Have them explain food deserts… and structural and environmental racism.”

Dr. Huchko stated that giving aspirin throughout pregnancy reduces preeclampsia, and is thus traditionally offered based on risk factors for preeclampsia, like low socioeconomic status and African American race. Sometimes, healthcare providers may not be able to address these risks without the acknowledgement of race as a risk factor. Dr. Huchko is right, African American women are at a higher risk for preeclampsia, and ignoring this correlation would probably do more harm than good. 

But per Dr. Mungo’s appeal, providers must interrogate these associations more deeply — and be ever anti-racist in their efforts — if they are to create the safe spaces and trusting relationships that Mahendru, Dr. Huchko, and Dr. Mungo each hope to see.

By Zella Hanson

Emergency Use Authorization for Covid Vaccine: One Hurdle of Many

Who will be the first company to secure an Emergency Use Authorization for a Covid-19 vaccine, and when? This question has circulated in the popular press for a few months and is at the forefront of many Americans’ minds with the upcoming presidential election on November 3rd.

Arti K. Rai (J.D.) moderated a dialogue between former FDA Commissioner and distinguished Professor of Cardiology, Robert Califf (M.D., M.A.C.C.), and Founder and Director of Scripps Research Translational Institute, Eric Topol (M.D.), in which the pair discussed emergency use authorization, public trust, and vaccines. The discussion was part of the Science & Society Initiative’s ongoing series of “Coronavirus Conversations.”

Emergency Use Authorizations (EUAs) strengthen American public health protections by speeding the availability and use of medical countermeasures during public health emergencies. Dr. Califf explained that in addition to events like nuclear catastrophes that EUAs were designed to provide protections for, pandemics were also thought about in conceiving the emergency measure. “[The pandemic] is not a surprise,” Califf said, “We knew it was going to happen at some point.”

The panelists examined the possible use of EUAs for a Covid vaccine and monoclonal antibody treatments given the EUAs issued earlier this year for hydroxycholoroquine and convalescent plasma, the former of which was revoked due to proven risks. Both of these experimental treatments lacked sufficient evidence at the time the EUAs were approved.

Dr. Topol said that the EUA case for the antibodies treatment is a good one with growing evidence that suggests their effectiveness as a viable treatment measure. Dr. Califf concurred, saying that with 1,000 people predicted to die every day in the U.S. through the end of December, there’s a strong case for the FDA to exert its judgment. One issue with antibodies, however, is that they cannot be made in large quantities and are very expensive, meaning they would be inaccessible for many.

The question of EUA use for vaccines is less straightforward. Dr. Topol argued that though the protocols released by four drug companies, including Moderna and Pfizer, are pretty far along, “there is a very questionable ethical story here.” He continued, “How can we say it’s good enough to give to essential workers, healthcare works, high-risk individuals, but they won’t even give it to trial participants? They received placebo vaccines.” Across the board, the trials currently underway only include about 150 individuals.

These initial trials are only the first hurdles to the production of a vaccine, according to both Califf and Topol. Dr. Califf pointed out that there will be issues of manufacturing and distributing, lots of concerns with post-market assessments, and how to determine which vaccines will be the best. Dr. Topol reinforced these ideas, suggesting that because no single company will be able to fill the vaccine demands, we need multiple vaccines to be successful. Further, Dr. Topol admitted his concern about the major extrapolations of data we will face, going from trials of 150 individuals to potential distribution numbers of vaccines reaching the hundreds of millions, if not billions of people.

And even once an initial round of vaccines is developed, Dr. Califf inserted the question, “What happens after people get vaccinated?” The simple truth is, the vaccination will probably not completely eradicate the virus, there could be late post-vaccination reactions, and the vaccine could potentially end up creating asymptomatic carriers. Both doctors agreed, masks and social distancing will be needed for at least the next year.

The potential of a Covid-19 vaccination has been popular in the media over the last few months.

Public opinion and politics are also key players in vaccine debates and development. “The point of public trust is essential because if something happens with the first vaccine that gets out,” Dr. Topol said, “it’s going to be a real damaging blow to vaccine rollout.” Like mask-wearing, Topol suggested that vaccines are part of a larger social contract in which these sorts of preventative measures not only help oneself but those around them.

Rai pointed out that as tensions between the FDA and the U.S. department of Health and Human Services grow, as well as between the FDA and the Trump administration, we could face “doomsday” scenarios where the FDA is coerced into certain actions and their powers become limited. However, new FDA guidelines for vaccine development have extended the potential timeline for a Covid vaccine, meaning that the chances of a EUA being issued before the election and being utilized as a political tool for Trump’s reelection are quite unlikely at this point.

Dr. Califf closed by emphasizing the need for solidarity among the biomedical community as influential to the success or failure of potential vaccines and public trust. Dr. Topol offered that we “need education, government that supports science, and need to get [support from] people of all diverse backgrounds to get [the public] to buy in.”

While Dr. Topol maintained a more skeptical and sometimes grim tone, Dr. Califf said that though he’s worried about “everything,” he’s “preparing for the worst but hoping for the best.”

It seems that as many people grow both accustomed to and tired of our new normal, most of us are caught somewhere in the middle of these outlooks.

Post by Cydney Livingston

Scholars Examine Duke’s History of Unequal Medical Care for Black People

Conversations on and actions toward making American medicine less racist continue to grow. At Duke, that includes looking at our own history as a hospital and medical center serving a diverse community.

In a Sept. 22 virtual conversation, Duke physicians Damon Tweedy M.D., Associate Professor of Psychiatry and Behavioral Sciences, and Jeffrey Baker M.D., Ph.D., Director of the Trent Center for Bioethics, Humanities, and History of Medicine, spoke about the history of Duke’s legacies of race and memory. (Watch the presentation here.)

The career of Dr. Baker, who is a professor of both pediatrics and history, has taken him around the globe, right back to his hometown of Durham –where he said he has found the most interesting story of all.

After becoming Director for the Trent Center in 2016, he was approached with “hunger” by Durham natives to know their hometown’s story. Through oral and archival sources, Dr. Baker has broached Duke hospital’s history with humility in hopes of uncovering and contextualizing the historical roles of race in Duke medicine and Durham.

Dr. Tweedy, author of Black Man in a White Coat, attended Duke for medical school in the 1990s. He was warned that it was a plantation and an institution built on tobacco and slave money.

Though Dr. Baker proposed that in many ways the hospital structure often reflects plantation hierarchies in which there is racialization of who holds what jobs and power, he said Duke’s endowment money actually came from technological progress within tobacco production rather than slavery or plantations directly.

The Duke family’s vision for the hospital was quite different from actual outcomes in practice, Dr. Baker said. The Dukes were considered racial progressives in their time and the endowment they provided to launch the Duke Medical School and Hospital in 1930 was meant to improve health and education in North Carolina and train primary care doctors for the state.

“However,” Dr. Baker said, “there were two realities: Jim Crow and the Great Depression.”

Dr. Tweedy and Dr. Baker via Zoom

During the era of Jim Crow segregation, Duke’s primary care doctors were all white, and nearly all male. Though the hospital cared for both Black and white patients, they were segregated by race. Black patients had separate wards, and waiting areas for pediatric care were separated racially by days of the week. Waiting areas for adult patients functioned without appointments, but only white people were seen before noon. It’s likely that the care granted to white people in the first half of the day was superior to that of Black people receiving care at 4 pm or told to return the next day, he said.

Original floor plans for the Duke Hospital.

The Great Depression also generated a diversion from plans in the 1940s. When the Duke Hospital came close to bankruptcy, it chose to open private clinics on the side for revenue – which had an unintended consequence. The clinics brought a lot of money into Duke, Dr. Baker said, but it also reinforced distinctions between those who could pay for treatment and those who couldn’t. Over time, the disparities expanded with shifts towards hospital beds for insured and private patients.

In one terrible example, Maltheus “Sunny” Avery, a North Carolina A & T graduate who got into a car wreck in Burlington, NC in 1950, was diagnosed with an epidermal hematoma — a clot near his brain — and sent to Duke for emergency brain surgery. But he was refused treatment due to inadequate room in the “colored” ward.

Avery was redirected to Lincoln Hospital, Durham’s Black hospital, where he died shortly after admission. Though Dr. Baker said this story quickly faded from white memory, it is something that has retained severe importance in the popular memory of Black Durhamites. This narrative is also often conflated with a similar story about Dr. Charles Drew, the Black inventor of blood banking, who died despite attempts at rescue at a white hospital in Alamance, NC. He is often misremembered as having died from the refusal of care in a racially divided South, even though he was not.

News coverage of Sunny’s death.

Duke’s first Black medical student, Delano “Dale” Meriwether, arrived the same year the hospital began desegregation, 1963, and he was the first Black M.D. in 1967. Meriwether was the only Black medical student for four years before other brave pioneers joined the school.

Dr. Tweedy reflected on his own medical school experiences at Duke during clinical rotations just a little more than 20 years ago.

“I was asked to help suture a deep gash on a Black patient’s forehead,” he said, “The patient asked if we were experimenting on him since I was still a student.” In the private clinics, he once “couldn’t go anywhere near” a white patent with a minor lesion on their arm, let alone suture that patient.

Dr. Baker said there are two narratives surrounding Duke Hospital’s desegregation. One assumes that desegregation was quick and easy and uneventful, while the other proposes that systems of racial segregation were simply transformed rather than eradicated. The latter narrative better applies to the public and private clinics that had become nearly completely racialized over time, Baker said.

Even though segregation was no longer legal,  Black patients received care from less experienced medical residents in the public clinics, while white patients received care from attending physicians in the nicer, private environments.

Dr. Baker said that Duke has a complicated relationship with the community of Durham. He said the merger of Durham Regional Hospital with Duke Health in the late 1990s tapped into some long-term tensions and distrust between Duke and other medical facilities of Durham.

Dr. Tweedy pointed out that Duke researchers always have trouble recruiting Black patients for clinical studies, despite the fact that Durham County is about half Black and Hispanic. There is some distrust to overcome, but a diverse patient population is essential to creating robust study data that ensures that treatments will work for everyone, he said.

Medical professionals “need more than just science,” Baker concluded. He said that being trained as scientists often inclines doctors to think that they are above the larger contexts and histories they exist within, and that they can somehow remain objective.

“We have come out of specific stories and backgrounds,” Dr. Baker said. “[When we treat patients], we have to think about what story we are walking into.”

“We all carry our bags of ‘stuff'” that complicate patient prognosis and care, Dr. Tweedy concurred.

As Ann Brown (M.D., M.H.S), Vice Dean for Faculty, stated at the beginning of the conversation, “In order to move forward, we must understand where we come from.”

This is true of our nation as a whole, and Duke is certainly no exception.

Post by Cydney Livingston

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