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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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FDA issues emergency authorization for first at-home COVID-19 test

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Nov. 18 (UPI) — The U.S. Food and Drug Administration has issued an emergency authorization for the first rapid coronavirus test that can be administered at home.

The agency announced the authorization for the all-in-one test kit late Tuesday in response to a request by Kelly Lewis Brezoczky of Lucira Health, the California-based company that developed the test.

In a letter to Brezoczky, the FDA said the test meets the criteria for an emergency use authorization as there are no available alternatives and the product’s benefits outweigh its known and potential risks.

The test has been authorized for use with samples collected from the nasal cavity of those age 14 years and older whose doctors suspect they have been infected with the coronavirus. Use in doctor’s offices, hospitals, urgent care centers and emergency rooms has been approved for all ages.

While there have been other products approved for collecting samples at home, the Lucira product is the first to be fully self-administered and to provide results without a physician’s assistance.

The company’s website said the test is intended to cost under $50 and is designed to provide results within 30 minutes.

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

FDA Commissioner Stephen M. Hahn said the development of a COVID-19 test that can be administered outside a healthcare setting has been a major priority for the FDA, and now that there is one more people who suspect that they may have been infected with the virus can take immediate action to protect themselves and their community.

“We look forward to proactively working with test developers to support the availability of more at-home test options,” he said.

The FDA approval was issued as the nation deals with a growing widespread outbreak. According to data collected by Johns Hopkins University, the United States has recorded more than 150,000 case a day in five of the last six days.

The United States has reported more than 11.3 million infections and nearly 250,000 deaths, making it by far the sickest country to the pandemic.



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Antidepressant might help prevent severe COVID-19

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The antidepressant drug fluvoxamine — best known by the brand name Luvox — may help prevent serious illness in COVID-19 patients who aren’t yet hospitalized, a new study finds.

The study included 152 patients infected with mild-to-moderate COVID-19. Of those, 80 took fluvoxamine and 72 took a placebo for 15 days.

By the end of that time, none of the patients who took the drug had seen their infection progress to serious illness, compared with six (8.3%) of the patients who took the placebo, according to researchers at Washington University School of Medicine in St. Louis.

“The patients who took fluvoxamine did not develop serious breathing difficulties or require hospitalization for problems with lung function,” said first author Dr. Eric Lenze, professor of psychiatry.

“Most investigational treatments for COVID-19 have been aimed at the very sickest patients, but it’s also important to find therapies that prevent patients from getting sick enough to require supplemental oxygen or to have to go to the hospital. Our study suggests fluvoxamine may help fill that niche,” Lenze noted in a university news release.

Fluvoxamine — widely used to treat depression, obsessive-compulsive disorder and social anxiety disorder — is a type of drug called a selective serotonin-reuptake inhibitor (SSRI). This class of drugs also includes medicines such as Prozac, Zoloft and Celexa.

But unlike other SSRIs, fluvoxamine has a strong interaction with a protein called the sigma-1 receptor, which helps regulate the body’s inflammatory response.

“There are several ways this drug might work to help COVID-19 patients, but we think it most likely may be interacting with the sigma-1 receptor to reduce the production of inflammatory molecules,” explained study senior author Dr. Angela Reiersen, associate professor of psychiatry.

“Past research has demonstrated that fluvoxamine can reduce inflammation in animal models of sepsis, and it may be doing something similar in our patients,” she said in the release.

By reducing inflammation, fluvoxamine may prevent a hyperactive immune response in COVID-19 patients. That, in turn, may decrease their risk of serious illness and death, Reiersen said.

“Our goal is to help patients who are initially well enough to be at home and to prevent them from getting sick enough to be hospitalized,” Dr. Caline Mattar, assistant professor of medicine in the Division of Infectious Diseases, said in the release. “What we’ve seen so far suggests that fluvoxamine may be an important tool in achieving that goal.”

Dr. Amesh Adalja is a senior scholar at the Johns Hopkins Center for Health Security in Baltimore. He wasn’t involved in the study, but said the research is “notable not only because of its positive outcome — we desperately need a medication that keeps COVID patients out of the hospital — but also because of the manner in which it was conducted.”

But Adalja stressed that a larger trial is needed “to see if the promising findings hold up.”

The researchers said they plan to begin such a study in the next few weeks and it will include patients from across the United States.

The preliminary study was published online Nov. 12 in the Journal of the American Medical Association.

More information

For more on COVID-19, go to the U.S. Centers for Disease Control and Prevention.

SOURCES: Amesh Adalja, M.D., senior scholar, Johns Hopkins Center for Health Security, Baltimore; Washington University in St. Louis, news release, Nov. 12, 2020

Copyright 2020 HealthDay. All rights reserved.



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Survey: 40% in U.S. planning large gatherings for holidays despite COVID-19 warnings

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Nov. 12 (UPI) — Nearly 40% of U.S. residents plan to participate in gatherings of 10 or more people this holiday season despite concerns over the spread of COVID-19, according to the findings of a survey released Thursday by Ohio State University.

In addition, one-third of respondents said they wouldn’t ask attendees at holiday parties with family or friends to wear masks, and just over 25% indicated that they wouldn’t practice social distancing, the data showed.

“We’re going to look back at what happened during this holiday season and ask ourselves, ‘Were we part of the solution or were we part of the problem?'” Dr. Iahn Gonsenhauser, part of the team that conducted the survey, said in a statement.

“When you’re gathered together around the table, engaged in conversation, sitting less than 6 feet apart with your masks down, even in a small group, that’s when the spread of this virus can really happen,” said Gonsenhauser, chief quality and patient safety officer at Ohio State University Wexner Medical Center.

Researchers at Ohio State surveyed more than 2,000 U.S. residents on their holiday plans in the context of the COVID-19 pandemic.

As of Thursday afternoon, nearly 10.5 million people nationally have been sickened by the virus, and more than 240,000 have died, according to figures from Johns Hopkins University.

In recent weeks, federal, state and local public health officials have advised against traveling or partaking in large social gatherings as the holiday season approaches to limit the risk of spreading the new coronavirus to vulnerable loved ones.

At the very least, they’ve asked that gatherings not happen without wearing a mask and practicing social distancing, or staying 6 feet apart.

Those at risk for severe COVID-19 include the elderly, as well as those with diabetes, heart disease and high blood pressure, all of which are common across the United States, according to the Centers for Disease Control and Prevention.

Still, 38% of respondents to the Ohio State survey indicated they would host or attend a gathering with 10 or more people during the holidays and 33% would not ask others to wear masks, the researchers said.

However, 73% of respondents said they would practice social distancing during the holidays and 79% suggested that they would celebrate or gather only with people with whom they live, the data showed.

Just over 80% indicated that they would ask family and friends invited to events not to come if they had symptoms of COVID-19.

“If you have someone in your household who’s high risk and you’re in a low incidence area, you’re going to want to think twice about having a celebration where people are coming from an area where there’s a lot of virus in the community,” Gonsenhauser said.



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