Black volunteers needed for COVID trials

MGN

According to the APM Research Lab, one in 1,000 Blacks in this country has died from COVID-19. Because the virus has had a disproportionate impact on the Black population and the COVID vaccine research is well underway, there is a need to recruit more Black volunteers for coronavirus vaccine trials.

A clinical trial is a research study in which participants voluntary take part in supervised treatments from doctors and other research professionals. Among the selection criteria are considerations of age, gender and previous medical conditions.

The trials typically consist of three phases before the Food and Drug Administration (FDA) approves a vaccine for mass distribution: 1) a sample size (usually fewer than 100) is selected; 2) volunteers are given the vaccine in various dosages; and 3) a larger group (tens of thousands) is selected for the vaccine to test its effectiveness.

The U.S. Department of Health and Human Services (HHS) says that if “a safe and effective [COVID] vaccine” is developed and made available early next year, approximately 150,000 research participants will be needed; at least 40% of these will need to be Black or Latino participants.

Black participation in clinical trials historically has been low mainly because of fear and mistrust of doctors and the medical community. The 1932 Tuskegee Experiment, in which rural Black men were unknowingly injected with syphilis by scientists and experimental surgeries performed on Black women without anesthesia, are often cited as reasons why Blacks don’t participate in clinical trials.

A Massachusetts-based company now working on a COVID-19 vaccine recently reported that only 4% of nearly 50 volunteers are Black.

There is also a lack of awareness about trials and economic considerations. “The story is always told from one angle,” explained Assistant Professor M. Kumi Smith of the University of Minnesota School of Public Health. “One type of angle is how [pharmaceutical] companies with those vaccine trials don’t really know much about how to do proper outreach in Communities of Color or outside the well-off, better-educated White folk.”

Smith nonetheless agrees that the fear and mistrust factor, which along with poor outreach by companies, logically explains the low Black participation in clinical trials. “It’s probably a combination of both things,” she pointed out.

Health Partners Occupational Medicine’s Dr. Zeke McKinney added, “We don’t want People of Color being experimented on.” Still, Blacks and People of Color participating in clinical trials are needed, he stressed.

“To make sure that we [as Blacks] are well represented…we won’t know how these vaccines will respond to the Black community. Making sure that we are adequately represented is absolutely the reason” it is important, he said.

“The inclusion of Black folk in trials is so important because we have to be able to demonstrate that we are using an approach to the development of the testing of vaccine on all kinds of people,” concurred Smith.

McKinney also dispelled the misinformation that the COVID vaccine contain the virus. “We are not expecting to give people the COVID,” he emphasized. “That doesn’t mean there are no risks.

“Part of phase two and phase three is to look for adverse effects,” the doctor continued. “Our processes are safe enough that if something does happen, we can immediately figure out what is going on.”

Having a “herd immunity” to evaluate the vaccine’s side effects is important as well, Smith added. “If we can’t reach that herd immunity, that threshold, we are not taking full advantage” of any vaccine.”

The National Medical Association (NMA) in August established a COVID-19 task force “to help address questions and concerns about efficacy, safety and allocation of COVID-19 vaccines,” said the group’s press release. The Black doctors’ group said the task force was needed because of political influence by the FDA and the White House to speed up a vaccine before the November 3 general election.

The MSR asked for comment from NMA officials, but our requests were not answered.

“It is not the first time science has become politicized,” said Smith, “but I never quite expected it to get so extreme as it has been.” She surmised that rushing a COVID vaccine too soon and without following the proper protocols is “doing a complete disservice, not just to the science community but also society at large.”

“We are trying to set up a pipeline” for more Black participation in clinical trials,” said McKinney. “I think it is the responsibility of people like myself who are trained in the field to get out there and try to rebuild some of that trust.”

About Charles Hallman

Charles Hallman is a contributing writer at the Minnesota Spokesman-Recorder. He can be reached at challman@spokesman-recorder.com

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