More than 1.2 million people in the U.S. are living with HIV, and 1 in 7 of those are unaware of their infection, according to statistics from AIDS.gov. African Americans account for 45 percent of HIV diagnoses, yet only 12 percent of the total U.S. population. Addressing critical racial and ethnic health disparities - particularly in HIV/AIDS outreach - is a primary part of Dr. Jonca Bull's role as the FDA's assistant commissioner for minority health.
Dr. Bull, who has been with the FDA since 2012, provides strategic leadership, coordination, and oversight for FDA’s minority initiatives and has been instrumental in coordinating FDA's response to the FDA Safety and Innovation Act of 2012 addressing demographic inclusion in clinical trials and outreach to underserved communities.
BlackDoctor.org interviewed Dr. Bull to learn more about the FDA's role in HIV/AIDS and the work being done to close the gap on health disparities.
BlackDoctor.org: What is the role of the FDA Office of Minority Health in promoting HIV/AIDS awareness and prevention?
Dr. Bull: We know that HIV/AIDS continues to be a growing problem in the Black community. Our role here at the FDA’s Office of Minority Health (OMH) is to promote and protect the health of diverse populations through research, communication, and outreach, with a particular focus on health disparities and health equity. We focus our efforts on improving the FDA’s communications with minorities and work closely with organizations like BlackDoctor.org to strengthen our messages and extend our reach. We make sure to meet people at their place of need and to develop communications that are timely, relevant, and culturally competent. We engage our audiences though social media (e.g. Twitter chats) and our website; develop health education resources to educate about the various diseases and health topics; serve as spokespersons for minority health at conferences and meetings; and we fund research on health issues that disproportionately affect blacks, like HIV/AIDS. For example, in 2012 we funded a project to establish an in-vitro vaginal epithelial cell infection model to examine the role of abnormal vaginal bacteria on increased risk for HIV-1 acquisition.
BlackDoctor.org: How does FDA policy affect those who are living with HIV or AIDS?
Dr. Bull: The FDA’s mission includes ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. For the HIV community, this means that we are responsible for making sure that the tests used to diagnose HIV are accurate and reliable, barrier methods (e.g. condoms) are monitored for quality assurance, treatment regimens are safe and efficacious, and the blood supply is safe for the nation. Additionally, the FDA works with industry and other government partners to develop preventive and therapeutic vaccines for HIV, develop practical microbicides to prevent spread of HIV, and ensure proper device sterilization in medical settings to prevent the spread of HIV.
BlackDoctor.org: What initiatives of the FDA have been most effective in reaching minority groups and reducing health disparities? How do you measure success?
Dr. Bull: One way the FDA has been effective in reaching minorities is through our “Diversity in Clinical Trials Initiative”. We are committed to encouraging participation of diverse patient populations in biomedical research used to support marketing applications for FDA-regulated products, like new HIV medications. Over the past two decades, the FDA has taken a multitude of steps to enhance representation of diverse populations in clinical trials through various initiatives and outreach strategies, including:
Last year, we launched our Diversity in Clinical Trials campaign where we featured an African American woman telling her story about participating in clinical trials and helping to dispel myths. This campaign included 6 videos, brochure, fact sheet, and other collateral materials, plus extensive social media outreach to help raise awareness.
We have encouraged participation of racial and ethnic groups in all phases of medical product development and believe that potential differences in responses to medical products in subgroups are important to the FDA’s efforts to ensure safety and efficacy is studied in those who will use these products once they are approved.
We recommend that risk/benefit be assessed for all affected demographic subgroups, including for example, geriatric patients who are far more likely to have multiple illnesses, receive multiple drugs and other treatments and often have co-morbidities that could interact with investigational drugs.
BlackDoctor.org: In African American communities, misinformation about or distrust of clinical trials are still prevalent. Tell us about the importance of clinical trials and how they work.
Dr. Bull: Historically, minorities have been under-represented in clinical trials. Inclusion of clinically meaningful subpopulations in clinical trials helps to properly evaluate the safety and efficacy of medical products.
When clinical trial participants reflect a diverse sample of the general population, and when the sub-population data are appropriately analyzed, much more information will be known about medical products and more meaningful clinical data can be communicated to the public. In summary, medical products are safer and more effective for everyone when clinical research includes diverse populations.
Clinical trials are the proving ground for new drugs, vaccines and devices. They provide data that will determine whether the FDA approves a manufacturer’s application for marketing approval. Potential racial, ethnic and other differences in response to drugs are important to the FDA’s efforts to help ensure that the safety and effectiveness of drugs are studied in all people who will use the products once they are approved.
Ensuring meaningful representation of minorities in clinical trials for regulated medical products is fundamental to the FDA’s regulatory mission and public health. The FDA is working to increase the participation of people in racial, ethnic and other minority groups in the clinical trials that test new medical products. For more information on minorities and clinical trials, click here.
BlackDoctor.org: Treatment of HIV/AIDS has advanced greatly in the last 30 years. What new research, policies or initiatives should we be aware of?
Dr. Bull: The FDA is part of the Department of Health and Human Services (HHS). Under the leadership of HHS, there are several initiatives underway to help prevent HIV and improve the health outcomes of people living with HIV. These include:
National HIV/AIDS Strategy- this plan charts the course for the federal government and other sectors to respond to HIV in the United States. This plan was developed with extensive stakeholder input and provides strategies, evidenced based practices, and lessons learned from the local, regional, and state levels.
Secretary Minority AIDS Initiative Fund (SMAIF)- this fund was established by Congress in 1999 and provides funding to HHS agencies to support programs to reduce new infections, improve HIV related outcomes, and reduce HIV related health disparities.
AIDS.gov- uses electronic communications, such as a website, blog, and social media to raise the profile of federally supported HIV information and services. AIDS.gov also helps to coordinate activities across HHS to help cross-promote key messages, policies, and resources.
HIV Treatment Works Campaign- this campaign is designed to raise awareness on how to overcome barriers to get in HIV care and stay on a treatment regimen.
To learn more about the laws governing the FDA’s role in clinical trial participation, FDASIA Sec. 907 and the FDA’s Action Plan, see below:
FDASIA Section 907: Inclusion of Demographic Subgroups in Clinical Trials (More about FDAISA in general can be found here)
FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data (August 2014)