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FDA data reveals racial discrepancies in cardiovascular drug trials

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Data from the U.S. Food and Drug Administration shows that Black Americans are recruited for drug trials at substantially lower rates than White Americans.

Seventy-five percent of cardiovascular drug trials reported from 2015-2019 had major racial discrepancies, according to recent data from the FDA. Nine out of the 12 trials report 80% or more White participants and less than 6% African American participants.

Previous research has revealed that, historically, minorities, women and those older than 65 have been underrepresented in clinical trials.

Dr. Clyde W. Yancy, chief of cardiology at Northwestern University’s Feinberg School of Medicine, said the problem of underrepresentation was so significant that in 2016 the “FDA introduced guidance to attempt to directly address it.” But, “in the absence of a mandate, the guidance has not yielded a major change.”

Several studies this year, including research by the CDC, have shown many deaths related to COVID-19 were due in part to cardiovascular diseases. And Black Americans, who are affected by heart problems at higher rates than White Americans, are disproportionately dying of COVID-19 in cities across the United States.

According to the CDC’s COVID-19 data tracker, while Black Americans make up 13% of the country’s population, Black non-Hispanic patients make up 22% of total deaths caused by the novel coronavirus.

An analysis by the American College of Cardiology supported the CDC’s findings, concluding that heart complications are common in patients suffering from COVID-19. And since there are no specific therapies available to target myocardial injuries sustained from COVID-19, Black people are at a higher risk of heart complications.

A question of trust

In the traditional drug trial model, clinical research coordinators and doctors, partnering with research organizations, handpick patients for drug trials. According to Yancy, with this model, mistrust and subconscious bias can cause significant racial discrepancies among the recruited participants.

“If the investigator or the investigation team doesn’t trust a patient to execute the trial dutifully then they won’t bring that patient into the trial,” Yancy said.

But trust goes both ways, he said. Patients can also opt-out from participating in a trial if they feel that an investigator isn’t transparent and honest about exposure and risk.

Black patients said the generational mistrust the Black community has toward medical professionals, which is largely based on experiments like the Tuskegee study, continues today.

“History has shown that in the past, healthcare trials have not always been favorable to African Americans,” said Elizabeth Corshu, a registered nurse and a heart patient.

Corshu said she was shocked that this experiment wasn’t taught in any of her nursing classes. “It was something that I learned on my own,” she said.

Doctors refuse care

During her pregnancy, Corshu was experiencing signs of heart failure. As a Black medical professional with almost 10 years of experience, she recognized the symptoms and reached out to her doctor but her continuous efforts were dismissed.

A week after the 30-year-old gave birth to twin boys, her symptoms started escalating. She found herself in the hospital describing the exact tests she wanted her doctors to complete.

The doctors were surprised when Corshu, a young patient with no history of heart problems or high blood pressure, showed signs of peripartum cardiomyopathy, a rare type of heart disease related to pregnancy.

Although Corshu was able to use her medical knowledge to advocate for herself, she was angry for the women that came before her who couldn’t.

A 2016 study showed 40% of first and second year medical students falsely believed that Black people had thicker skin than white people and thus a higher tolerance for pain. According to the Association of American Medical Colleges, Black people’s pain is often disregarded and under-treated, which can have fatal consequences.

After her diagnosis, Corshu was approached about participating in an experimental drug trial, but she refused. She said in order to build goodwill within the Black community, drug companies need to be transparent with their goals and have some involvement within the community instead of trying to turn a profit through a new drug.

Darlene Scott, 45, participated in a cardiomyopathy study with Pfizer over two years ago and is a participant in a lifelong study for sarcoidosis, an autoimmune disease that caused her to have an enlarged heart.

Scott, an associate professor at the Virginia Union University, said that, in general, the Black community has great mistrust toward medical professionals and she understands why.

“So many tests and trials have been done on us without our permission and they’ve had detrimental effects,” she said.

According to Yancy, unless the FDA’s guidance of diverse representation in clinical trials becomes a requirement, particularly National Institutes of Health directed studies, the racial discrepancies will not get much better.

Improving situation?

However, Yancy is hopeful. He said, typically, the representation in drug trials today is closer to 20% for non-White participants. He said the FDA data, which shows Black or African American participation at less than 6% in most cardiovascular clinical trials, is not representative of all past or on-going studies.

In fact, according to a 2018 NIH report, which included data from 22 NIH funded institutions, about 24% of participants in cardiovascular clinical trials identified themselves as non-White — 15% of these participants were Black.

In contemporary clinical research, large academic medical systems, like Northwestern Medicine, have private electronic databases that compile information on all patients that visit Northwestern affiliates. Instead of handpicking participants, clinical researchers and clinical trial coordinators allow computers to filter through the database to find patients who fit their criteria.

Yancy said that although electronic databases are better at combating bias compared to the traditional model, there’s still inequity that stems from socioeconomic status, especially when considering who can afford to visit private hospital systems.

Amgen Inc., Novartis International AG and Portola Pharmaceuticals, companies with cardiovascular drug trials in the FDA database, declined multiple requests to comment on the racial inequalities of their respective studies.

Pfizer Inc., however, pointed out that at least one of its studies featured proportion of Black participants similar to population estimates in the United States.

“We prefer to focus our limited media resources on the company’s multi-prong efforts to address COVID-19,” the spokesperson said. “Beyond that, it seems very misguided to highlight as an example the participant diversity of our Vyndaqel ATTR-ACT trial, especially since 14% of patients in that trial were Black — roughly the U.S. national average for African Americans based on U.S. Census population estimates.”

While Yancy said that racial disparities have decreased under the current model, there is still room for improvement.

“The future is a place where we have a universal learning health system, where engagement in clinical research is almost entirely passive,” Yancy said. “Every patient who comes into the health system is a candidate,” which would reduce subconscious bias and inequities created by socioeconomic status.

He also said that participation in clinical trials should be non-controversial and a “component of citizenship,” but would require a cultural shift in order to break the enduring mistrust between Black people and the medical community.

“[The culture] needs to move away from cynicism, distrust, fear and uncertainty,” Yancy said. “This is part of our responsibility as citizens.”



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Kids’ ‘green’ time reduces adverse effects of ‘screen’ time on behavior, learning

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Sept. 4 (UPI) — More time spent outdoors — and less in front of a screen — leads to improved mental health in children and adolescents, according to an analysis of existing research published Friday by the journal PLOS ONE.

Based on data from 186 previously published studies, researchers determined that young people who spent more time on handheld games and devices, television and computers were more likely to have behavior and emotional problems and display symptoms of aggression and attention deficit-hyperactivity disorder.

The young people also were more likely to have learning or social difficulties.

Conversely, children who spent more time outdoors and who had increased access to “green” spaces for play and learning were less likely to have these undesirable traits.

“Overall, the studies showed that high levels of screen time were associated with poorer psychological well-being, while more green time was associated with better psychological well-being,” co-author Tassia Oswald told UPI.

“While a lot more work needs to be done in this field to help us understand why this is the case, it is important that [technology] doesn’t become the only thing young people do in their leisure time,” said Oswald, a doctoral student in public health at the University of Adelaide in Australia.

The prevalence of mental health illness among children and adolescents is increasing globally, according to Oswald and her colleagues.

In the United States, roughly 7%, or 4.5 million, of children ages 3 to 17 have been diagnosed with a behavioral problem, the Centers for Disease Control and Prevention estimates.

On average, American children and adolescents spent between four and six hours per day watching or uses devices with screens, and may be exposed to violence and misleading or inaccurate information, among other potentially problematic content, according to the American Academy of Child and Adolescent Psychiatry.

A separate study of 1,239 8- to 9-year-olds in Melbourne, Australia, published earlier this week by PLOS ONE, found that watching two or more hours of television per day at that age was associated with lower reading performance compared to peers two years later.

In addition, using a computer for more than one hour per day was linked to a similar reduction in their ability to understand and work with numbers.

However, no links were found between the use of video games and academic performance, the analysis showed.

Preliminary evidence suggests that green time potentially could limit the effects of high screen time, meaning nature may be an under-utilized public health resource to promote youth psychological well-being in a high-tech era, according to Oswald and her colleagues.

“Monitoring screen time can be difficult for parents — especially at the moment when many children have transitioned to online learning due to COVID-19 lockdowns,” Oswald said.

“Trying to encourage a balance of activities is good — so if a child spends an hour on a video game, encourage them to get outside for an hour.”



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Study: Common cold may help prevent flu, perhaps COVID-19

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Sept. 4 (UPI) — The virus most often behind the common cold is capable of preventing the flu virus from infecting airways by jump-starting the body’s immune defenses, a study published Friday by The Lancet Microbe found.

Now, the researchers from Yale University, want to determine if rhinovirus, the most common cold-causing virus, offers similar protective effects against COVID-19.

In an analysis of more than 13,000 patients with symptoms of a respiratory infection, those who had rhinovirus were not simultaneously infected with the flu virus — even during months when both viruses were active.

The finding may help explain why an expected surge in cases of H1N1 swine flu, predicted for Europe in fall 2009, never occurred, the researchers said.

It’s possible that the H1N1 virus was unable to infect those who already had the common cold, which was widespread at the time, they said.

“Infection with the common cold virus protected cells from infection with a more dangerous virus, the influenza virus, and [this] occurred because the common cold activated the body’s general antiviral defenses,” study co-author Dr. Ellen F. Foxman told UPI.

“This may explain why the flu season, in winter, generally occurs after the common cold season, in autumn, and why very few people have both viruses at the same time,” said Foxman, an assistant professor of laboratory medicine at Yale School of Medicine.

Concern has risen over the potential overlap of the COVID-19 pandemic with the annual flu season in the United States.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, recently said that the level of new cases of the coronavirus across the country is “too high.”

If cases continue to rise as flu season approaches, Fauci said, people infected with either of the two viruses, or both, could overwhelm the U.S. healthcare system.

“There [have been] a few reports of influenza-COVID-19 co-infections earlier in the year, and many of us are quite concerned what an influenza epidemic added to the COVID-19 pandemic could do,” Dr. Tony Moody, an associate professor of pediatric infectious diseases and immunology at Duke University Medical Center, told UPI

“At this point, we don’t really know what the two diseases will look like, or if other respiratory viruses will help or hurt during the current pandemic,” said Moody, who was not part of the Yale research.

For this study, Foxman and her colleagues analyzed nasal and throat specimens collected from 13,707 people with evidence of a respiratory infection. Just over 7% of the specimens tested positive for the rhinovirus, while just under 7% had confirmed influenza A infection.

Only 12 people in the study population had evidence of both viruses simultaneously, the researchers found.

To test how the rhinovirus and the influenza virus interact, Foxman and her colleagues created human airway tissue with epithelial cells, which line the airways of the lung and are a chief target of respiratory viruses, grown from stem cells.

After the tissue had been exposed to rhinovirus, the influenza virus was unable to infect the tissue because the cells’ antiviral defenses were already turned on before the flu virus arrived, Foxman said.

The rhinovirus triggered production of the natural antiviral interferon in the cells. Interferon is part of the early immune system response to the invasion of pathogens, Foxman said.

The protective effect offered by this new interferon lasts for at least five days, she said.

The findings may allow researchers to better predict how respiratory viruses spread and find new ways to combat them in the absence of vaccines, the researchers said.

They emphasized, however, that whether the annual seasonal spread of the common cold virus will have a similar impact on COVID-19 remains unknown.

“Our results show that interactions between viruses can be an important driving force dictating how and when viruses spread through a population,” Foxman said.

“Since every virus is different, we still do not know how the common cold season will impact the spread of COVID-19, but we now know we should be looking out for these interactions.”



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People who don’t believe in God may get better sleep, study says

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Atheists and agnostics are much more likely to sleep like an angel than Catholics and Baptists, a new study finds.

It included more than 1,500 participants in the Baylor University Religion Survey who were asked about their religious affiliation, behaviors and beliefs, as well as their average nightly sleep time and difficulty getting to sleep.

While 73% of atheists and agnostics said they got seven or more hours of nightly sleep, only 63% of Catholics and only 55% of Baptists said they got at least seven hours of sleep a night, preliminary data show.

Seven or more hours of sleep a night is recommended by the American Academy of Sleep Medicine, or AASM, for good health.

Catholics and Baptists were also more likely to report having difficulty falling asleep than atheists and agnostics.

Study participants who said they slept seven or more hours per night were much more likely to believe that they would get into heaven, compared to those who got less sleep.

However, beliefs about getting into heaven weren’t linked with difficulty falling asleep at night.

The researchers said that better sleep results in a more optimistic outlook and that in this study, that manifested as people believing they’d get into heaven.

“Mental health is increasingly discussed in church settings — as it should be — but sleep health is not discussed,” said study author Kyla Fergason, a student at Baylor University in Waco, Texas.

“Yet we know that sleep loss undercuts many human abilities that are considered to be core values of the church: being a positive member of a social community, expressing love and compassion rather than anger or judgment, and displaying integrity in moral reasoning and behavior,” Fergason said in AASM news release.

“Could getting better sleep help some people grow in their faith or become better Christians? We don’t know the answer to that question yet, but we do know that mental, physical and cognitive health are intertwined with sleep health in the general population,” she noted.

The findings were recently published in an online supplement of the journal Sleep, and were presented last week at the virtual annual meeting of the Associated Professional Sleep Societies.

More information

The National Sleep Foundation has more on sleep.

Copyright 2020 HealthDay. All rights reserved.



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