Sen. Warner, Colleagues Call for Diversity in COVID-19 Pharmaceutical Trials

From Sen. Mark Warner’s office:

WARNER, COLLEAGUES CALL FOR DIVERSITY IN COVID-19 PHARMACEUTICAL TRIALS

~ Urge pharmaceutical companies to ensure new treatments work for all communities across the country ~ 

WASHINGTON – U.S. Sen. Mark R. Warner (D-VA) joined Sen. Bob Menendez (D-NJ) and a group of Senate colleagues in urging pharmaceutical companies engaged in COVID-19-related work to prioritize diversity in any coronavirus vaccine or trial. Given the disproportionate impact of the outbreak on communities of color and other minority groups, the senators requested that any vaccine or therapeutic drug trial related to COVID-19 includes women, minorities, and LGBTQ+ persons. They also underscored the critical need for comprehensive demographic and racial data to ensure that new treatments work for all Americans. 

“The disparities in the COVID-19 pandemic are exacerbated by higher rates of chronic disease among many minority populations, inequitable access to health care, and bias within the health care system itself.  As such, any clinical trials for vaccines and therapeutic treatments of COVID-19 must include participants that racially, socioeconomically, and otherwise demographically represent the United States,” wrote the Senators. “This virus is striking in its disproportionate impact on minority populations, and it more important than ever that these populations are represented in any clinical trials.” 

“The FDA alone cannot fix the problem of underrepresentation.  The private sector must also take proactive steps to ensure drug and vaccine trials include a diverse group of Americans,” the senators continued.  “We urge you to examine new and creative ways to enroll a diverse set of participants in COVID-19-related trials such as reducing barriers to clinical trials, utilizing diverse clinical trial personnel, ensuring language accessibility, and investing in participant recruitment by partnering with minority health and community advocacy groups.” 

In letters to the CEOs of Abbot Labs, Abbivie, Amgen, Astra Zeneca, Bayer, CSL Behring, Eli Lilly, Genetech, Gilead, GSK US, Johnson & Johnson, Novartis, Pzifer, Regeneron, Sanofi and the Biotech Innovation Organization (BIO), the Senators also underscored that the disparities in the COVID-19 pandemic for many minority populations are exacerbated by higher rates of chronic disease, inequitable access to health care, and bias within the health care system itself. 

The senators also cited “alarming” research showing that, while African Americans represent 12 percent of the national population, they make up only 5 percent of all clinical trial participants. The numbers for Hispanics are even more stark at 16 percent and 1 percent, respectively. 

In addition to Sens. Warner and Menendez, the letters were signed by Sens. Chris Van Hollen (D-MD), Tom Carper (D-DE), Elizabeth Warren (D-MA), Richard Blumenthal (D-CT),  Bob Casey Jr. (D-PA), Dick Durbin (D-IL), Ben Cardin (D-MD), Mazie Hirono (D-HI), Edward J. Markey (D-MA), Bernie Sanders (I-VT), Cory Booker (D-NJ), Sherrod Brown (D-OH), and Amy Klobuchar (D-MN). 

Throughout this outbreak, Sen. Warner has pushed to make sure that we have the data needed to understand the scope of the crisis and its effect on diverse communities. He has previously introduced legislation to require the Department of Health and Human Services (HHS) to collect and report racial and other demographic data on COVID-19 testing, treatment, and fatality rates, and provide a summary of the final statistics and a report to Congress within 60 days after the end of the public health emergency. He has also urged the coronavirus taskforce only to distribute accurate information about the virus and dispel misinformation or discriminatory rhetoric to help prevent suspicion, panic and race-based assaults against Asian-Americans. Additionally, he has requested that the Vice President correct the record on mixed Trump administration messages related to COVID-19.  

The full text of the letter is available below. Download the letter to pharmaceutical companies here and to the Biotech Innovation Organization here. 

We write to request that you ensure that any vaccine or therapeutic drug trials related to COVID-19 includes women, minorities, and LGBTQ+ persons. As the nation continues to respond to the COVID-19 pandemic, we know from history that we cannot afford to get this wrong—we must understand what treatments work for all communities in America. 

In a matter of weeks, we have learned COVID-19 has a particularly devastating impact on racial minorities, like so many diseases that have come before it.  According to a Washington Post analysis of early data, COVID-19 “appears to be infecting and killing black Americans at a disproportionately high rate.”   Specifically, the analysis shows “that counties that are majority-black have three times the rate of infections and almost six times the rate of deaths as counties where white residents are in the majority.”   In New Jersey, where demographic data is available, Hispanics and African Americans account for 25.8 percent and 25.7 percent of COVID-19 cases respectively.   This is despite the fact Hispanics make up only 20.6 percent of the State’s population, and African Americans only 15 percent.   In Milwaukee County, Wisconsin, “African Americans account for about 70 percent of the dead but just 26 percent of the population.”   In Chicago, African American residents have died at a rate six times that of whites.   The disparities likely persist in other groups as well.  As Chicago Mayor Lori Lightfoot acknowledged, there is likely “‘significant underreporting’ among Hispanics, who account for roughly 14 percent of [Chicago’s] known [COVID]-19 cases and are 29 percent of the city’s overall population. Asians, representing about 7 percent of the population in Chicago, make up about 3.6 percent of known coronavirus cases.”   In Michigan, African Americans account for 13.4 percent of the population but make up a disproportionate 33 percent of COVID-19 cases and 40 percent of deaths. 

The disparities in the COVID-19 pandemic are exacerbated by higher rates of chronic disease among many minority populations, inequitable access to health care, and bias within the health care system itself.  As such, any clinical trials for vaccines and therapeutic treatments of COVID-19 must include participants that racially, socioeconomically, and otherwise demographically represent the United States.  This virus is striking in its disproportionate impact on minority populations, and it’s more important than ever that these populations are represented in any clinical trials.

Alarming research shows that although “African Americans represent 12% of the United States population, they make up only 5% of all clinical trial participants.  Only 1% of clinical trial participants were Hispanic, though they comprise 16% of the national population.”   As a result, “[i]nequitable research can lead to dangerous outcomes for those who are not represented in clinical trials.  Drugs including chemotherapeutics, antiretrovirals, antidepressants, and cardiovascular medications have been withdrawn from market due to differences in drug metabolism and toxicity across race and sex.” 

As the Food and Drug Administration (FDA) notes, “[r]acial and ethnic minority populations continue to be underrepresented in clinical trials and remain disproportionately burdened by many chronic and debilitating diseases. This is due to factors including a lack of trust in the medical system—in part due to historical mistreatment—as well as a lack of transportation, time, or knowledge about clinical research opportunities.”   Recognizing these inequities, the FDA issued guidance on the collection of race and ethnicity data in clinical trials and created a Minorities in Clinical Trials Initiative.  

The FDA alone cannot fix the problem of underrepresentation.  The private sector must also take proactive steps to ensure drug and vaccine trials include a diverse group of Americans. We urge you to examine new and creative ways to enroll a diverse set of participants in COVID-19-related trials such as reducing barriers to clinical trials, utilizing diverse clinical trial personnel, ensuring language accessibility, and investing in participant recruitment by partnering with minority health and community advocacy groups. Thank you for your continued work during this pandemic. We look forward to your response and thank you for your consideration of this important issue.

Sincerely,