Hepatitis Awareness: With a little Hep from the FDA
May is the time of the year for the FDA to alert the 2/3rds of the millions of Americans with hepatitis who are not even aware that they are infected. This year, however, the federal agency has partnered with the CDC to dig even deeper and reach two of the minorities that are more prone to suffer from inflammation of the liver; Asian/Pacific Islanders and African Americans. Chronic hepatitis is characterized by such symptoms as nausea, abdominal pain, jaundice, joint pain, and malaise, and can result in cirrhosis, end-stage liver disease, cancer, and other complications.
· Comprise 50% or more of Americans with chronic hepatitis B.
· Are 7 times more likely to die from hepatitis B.
· Comprise 25% of patients with hepatitis C.
· Aged 45 to 65 years old have Hep C-related chronic liver disease as their leading cause of death.
· Have a Hep C mortality of 8% as opposed to 4% for whites.
· Are primarily affected by sickle cell disease, which puts them at risk for hepatitis if they were given a blood transfusion before 1992.
The “FDA is committed to advancing the health, safety, and well-being of all Americans through the regulation of diagnostic tests, medicines, and vaccines, as well as monitoring post market safety of healthcare products and ensuring diversity in clinical trials,” National Institutes of Health Public Health Analyst Jovonni R. Spinner writes in the FDA Voice Blog. “One area that my office specifically focuses on is increasing diversity in clinical trials. Data has shown that African Americans and other races respond differently to hepatitis treatments. For example, in the VIRAHEP-C clinical trial, 28% of African-Americans were cured by the tested treatment, compared to 52% of whites.”
According to Spinner, these figures underline the importance of increasing participant diversity in clinical studies in order to learn how different groups react to products that fall under the regulation of the FDA. To that effect, the minority health initiative known as the FDASIA 907: Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data has been established to achieve three specific goals.
- Improve quality and quantity of data derived from under-represented groups in clinical trials.
- Increase their participation in clinical trials.
- Make data from clinical trials publically available.
Whether you’re a minority or not, remember that May 19th is National Hepatitis Testing Day but it is not the only day. Therefore, help yourself to the following resources: