Author: Dr. Asefa

As COVID-19 Phase 3 vaccine studies begin, minority participation in clinical trials is crucial

The minority community’s relationship with the medical and scientific world has not been built upon trust. This is particularly true with African Americans. Brutal and unethical historical practices in medicine subjected African American bodies to dissection and autopsy material without their consent. In addition, sterilizing Native American women without their consent, and the infamous Tuskegee syphilis experiment, led to a justifiable fear and luck of trust by people of color regarding clinical trial participation in the United States.

Recent publications have also indicated African Americans are overly represented in experimental and procedural studies that did not require informed consent. These are studies conducted under emergency situations when subjects cannot make an informed decision. Part of the explanation given was that African Americans represent the largest proportion of geographical catchment in areas where such experiments are done. These are primarily in inner city metro areas where academic medical centers are located. On the contrary, African Americans constituted less than five percent of patients in cancer-related clinical trials, which led to 24 of the cancer drugs approved between 2015 and 2018. The underrepresentation of African American in oncological clinical trials extends to cancers that have higher rates of occurrence in the African American community. If we follow the same logic for studies that did not require consent, studies on medical conditions that affect African Americans at a disproportionately higher rate (like multiple myeloma) should have a proportionate or higher ratio of African American subjects in the clinical trial.

The system is not serving justice and must change. Clinical trials can provide earlier access to care options that can prolong life and prevent disease.

Opinions differ in terms of the benefit of vaccines to society. I strongly believe in the positive impact of vaccines. The world eradicated small pox and controlled polio, measles, yellow fever,

pertussis, etc., with vaccine intervention. We must remember how human health was affected in the pre-vaccine era, when millions died with each major

epidemic.

I grew up in a developing nation where infectious disease accounts for the

majority of preventable deaths. I witnessed first-hand the impact of mass vaccination. I cannot imagine what the population demography would have looked like if public health were not armed with mass vaccination strategies for major childhood illnesses. As we progress in the fight against COVID-19, a safe and effective vaccine would give us the means to resume normal life.

Vaccine trials will show the result of preventing disease, or modifying the course of a disease, in a population that has the highest burden of disease. People at the highest risk of the disease— like healthcare workers, frontline workers, and African American and Hispanic communities— must be included in the study design that identifies requirements for participating in the trial. But protocols will not increase participation in

the study unless the trust and fear barriers for clinical trial participation are

addressed.

When it comes to COVID-19 vaccine clinical trials, early educational intervention to the underrepresented African American and Hispanic communities can improve the knowledge gap. Logistical factors that will curtail access to clinical research sites have to be considered. For example, trial managers should think about creating access to transportation, or taking clinical trial sites to where the target cohorts reside.

While building trust takes a long time, involvement of nonmedical community leaders to champion care in their respective communities will have a positive

influence. Primary care physicians who have longstanding relationships with communities should be involved in

recruitment and the explanation of

research protocols, as they have built rapport with their communities.

Having quantitatively and qualitatively proportionate racial, cultural, and ethnic representation on the team of clinical investigators— and among the teams who monitor the observance of rules of clinical investigation— can couple with a compassionate support staff during clinical trials to improve the trust factor. While medicine is a universal human science that assumes each of us should have commitment and care based on our common humanity, historical reasons in America have made race a major factor in care delivery. As such, we must bridge the gap so the community that needs care the most can benefit from early clinical trials and scientific progress to change the course of COVID-19 pandemic.

Asefa Mekonnen, MD, FCCP, is a pulmonologist in active practice as a partner at Rockville Internal Medicine Group in Rockville, Maryland. He also serves as an investigator with Meridian Clinical Research to oversee clinical

trials.

African American Policy Makers Urged To Take More Actions To Protect African Americans From The Coronavirus Or Multiple Deaths Will Continue To Occur

As a pulmonary and critical care medicine consultant and physician, I am urging African American policy makers to take more actions to protect African Americans from the coronavirus. If not, multiple deaths will continue to occur.

As of April 28, 2020, it was estimated that 3,042,444 people had been infected with coronavirus worldwide, with 211,216 fatalities. In the United States alone, 1,010,313 had contracted the virus, with 56,649 deaths reported. The cities of Chicago, New Orleans, Las Vegas and South Carolina have reported numerous deaths of African Americans due to COVID-19.

In Maryland, Governor Larry Hogan called the disparity among African Americans “disturbing.” Black Marylanders make up 52 percent of the deaths from coronavirus, despite only being 31 percent of the state’s population. In Chicago, 68 percent of the deaths were recorded as African Americans, although that group is only 30 percent of the population.

In Louisiana, where African Americans make up 33 percent of the population, data shows they represent more than 70 percent of COVID-19 deaths. In Albany, GA, which has the highest number of deaths from COVID-19 in the state, more than 90 percent of the fatalities are African-American.

It is no secret that a high number of African Americans are at risk for exposure to, and infection from the virus

because of multiple socio-demographic factors. They will do worse once they get the disease due to pre-existing chronic medical conditions like hypertension, diabetes, heart disease, asthma, and sleep apnea.

In addition, many African Americans and other people of color work in the service sector as custodians, grocery store workers, bus drivers, postal employees and agriculture workers. They are considered essential to their companies.

As an outspoken advocate of health disparities affecting the African American community, I recently told members of three policy organizations that,

despite African Americans being disproportionately impacted, very little is being discussed as a solution to protect this vulnerable population.

In a conference call on April 24, 2020, I addressed members of the Historic Black Towns and Settlements Alliance, Inc. (HBTSA); National Policy Alliance; and World Conference of Mayors.

I urged these influential African American policy makers to take more actions to protect the most vulnerable in our communities. I recommended several solutions that I believe could keep us from losing a generation.

I noted that more strategies should be put in place for this group that exceeds social distancing and staying at home.

Staying at home is a luxury for many low-income and poor families where people have to go to work to make ends meet. An African American COVID-19 patient may have a difficult time having a separate bed and bedroom to convalesce at home without infecting his or her family member. “Domestic spread” is a major threat to many African American families.

I pointed out how misinformation that African Americans cannot get the virus has been detrimental to the population. Fueled by the absence of coronavirus cases in Africa, initially, and the belief that the virus was associated only with foreign travel, many African American on-line sites made light of the deadliness of COVID-19.

As a result, a strategy needs to be put into place immediately with solutions that will prevent and mitigate further loss of life, with the focus on immediate and long-term goals. Urgent action plans should include a targeted educational campaign to correct misinformation about the effect of COVID-19 on persons of color.

African American media outlets, religious groups, and celebrities should

intensify any present efforts on their part. Physicians and health care pro- viders of color should step up and join the information campaign. It is well documented that the African American community has a lack of trust in the overall health care system due to unethical and cruel experiments of the past.

To reduce the risk of domestic exposure, infection and multiple deaths of African American family members who reside in crowded and multigenerational homes, patients with COVID-19 should be given special treatment. These individuals should be offered a separate makeshift recovery facility with provision of appropriate medical and social care. Targeted testing of contacts needs to include mobile testing units that can navigate the neighborhoods taking the test to where it is needed.

Additionally, the distribution of free face masks, disinfectants and food should follow a similar route. Long-term strategies must include access to Internet connectivity in low-income families for virtual medical care. There must be environmental justice to improve air quality in low-

income neighborhoods to improve respiratory health. There must also be more emphasis on proper nutrition.

Lastly, we must also address economic fairness to include differential compensation for high-risk front line jobs. Health is a basic human rights issue.

This needs a coordinated, well thought out national program that will ultimately lead to health and economic equality.

The status quo has been a disgrace to the wealthiest nation of the world. After multiple casualties, actions should be proactive and reactive.

In the past, segregation, racial inequalities and blatant discrimination trapped people of color in abject poverty where affordable healthcare and affordable housing were out of reach. The results of which is rearing its head today. African American stakeholders can make a difference by wielding their influence today to protect the most vulnerable in society.

A former pulmonary section head at Suburban Hospital – Johns Hopkins Medicine and a consultant intensivist in Critical Care Medicine at Shady Grove Adventist Hospital in Gaithersburg, Dr. Asefa Jejaw Mekonnen is a partner at Rockville Internal Medicine Group.