A group of community advocates have written the FDA with concerns about a study of a new hepatitis C drug that initially excluded African Americans. The study, sponsored by Schering-Plough, investigates different doses of SCH 503034 (a new hepatitis C protease inhibitor) in combination with Peg-Intron (pegylated interferon), with or without ribavirin. The initial study design called for the enrollment of 300 people with hepatitis C genotype 1 who did not respond to prior hepatitis C treatment. The study was recently amended to add an additional group who would receive a higher dose of SCH 503034 (800 mg, compared to initial doses of 100, 200, or 400 mg) in combination with Peg-Intron; this higher-dose arm allows enrollment of African Americans.
There's been some debate within the community about Schering's initial exclusion of African Americans from this study, with different perspectives on the scientific justification (which hinges on the well-established fact that for unknown reasons, African Americans have lower overall response rates to interferon-based treatment for hepatitis C) and ethical issues. For some perspectives, see the following articles and posts:
Press release (PDF) and background document (PDF) from the Hepatitis C Action and Advocacy Coalition (HAAC) and Community HIV/AIDS Mobilization Project
No Blacks Allowed? A Drug Trial Comes Under Fire - article from Poz Magazine, April 5, 2006
Advocates Slam 'Racist' Drug Trial - article from Newark Star Ledger, March 29, 2006
Blog posts from Karama C. Neal here and here
See also Test for All, Cure for All - a blog from Hepatitis C Multicultural Outreach.
Download the letter to the FDA here, or read the text by clicking on the link below.
