Dr. Debra B Birnkrant
DHHS/FDA/CDER/OND/OAP/DAV
Director, FDA Division of Antiviral Products
White Oak CDER Office Building 22
10903 New Hampshire Avenue
Silver Spring MD 20993

Dear Dr. Birnkrant,

We are writing to express outrage about the exclusion of African Americans from Schering-Plough's phase II trials of SCH 503034, an investigational hepatitis C protease inhibitor. Study NCT00160521 is evaluating multiple doses of SCH 503034 in combination with Peg-Intron, with and without ribavirin, in people with hepatitis C who did not respond to prior treatment. The exclusion began at the time of study initiation in September 2005 and continued until March 2006, when the protocol was amended to create an additional dosing arm that permitted African Americans to enroll. However, the amendment does not remedy the fundamental problems with Schering's study design.

Schering-Plough's initial exclusion of African Americans-the highest-prevalence population in the United States-was scientifically unjustified and ethically unacceptable. A hallmark of clinical research is the principle that each prospective research participant should have the opportunity to make an informed decision about the relative risks and benefits of participating in a clinical trial.

We cannot overemphasize the importance of obtaining a complete picture of the relative safety and efficacy of SCH 503034 and other experimental therapies in African Americans, including during early stages of research when safety, dosing, and pharmacokinetics/ pharmacodynamics are explored. Higher prevalence of hepatitis C and suboptimal response rates to current treatment among African Americans make it incumbent upon pharmaceutical sponsors of novel therapies to design trials that provide sufficient data at the time of licensure about how drugs perform in the people most likely to use them. Registration trials of pegylated interferon failed to produce this data due to low enrollment of African Americans. As a result, African Americans with hepatitis C and their clinicians were forced to make decisions about the relative risks and benefits of treatment based on inadequate information. This scenario must not be allowed to recur with promising new agents currently in, or soon to enter, clinical trials.

Relevant and timely data on Schering's 503034 can only be generated by enrolling adequate numbers of African Americans in phase III trials to power statistically meaningful subgroup analyses of response to treatment by race. We ask that FDA strongly encourage Schering to address this issue in its communications with the company, request and review detailed plans for statistical analysis and recruitment, and, if necessary, recommend changes in the phase III program as appropriate. Relegating research on African Americans and SCH 503034 to a later post-marketing commitment would represent a gross failure and injustice on the part of both Schering-Plough and the FDA.

Finally, Schering's exclusion of African Americans from study NCT00160251 must not set a precedent for future trials of other investigational agents. We request that the FDA work with companies pursuing new hepatitis C therapies on designing robust development programs capable of generating clear profiles on the relative safety and efficacy of these agents in African Americans. We urge the FDA to advise sponsors that any neglect of their responsibilities to African Americans with hepatitis C will be reflected in the drug's labeling at the time of approval.

We will convey these concerns to Schering-Plough and other companies involved in hepatitis C drug development, and look forward to a productive dialogue with FDA on this crucial issue.

Sincerely,

Community HIV/AIDS Mobilization Project (CHAMP)
594 Broadway
Suite 700
New York, NY 10012
www.champnetwork.org/

Harm Reduction Coalition
22 West 27th Street, 5th Floor
New York, NY 10001
www.harmreduction.org

Hepatitis C Action and Advocacy Coalition (HAAC)
53 Divisadero Street
San Francisco, CA 94117-3210
HAAC_SF@hotmail.com

Hepatitis C Multicultural Outreach
10603 Blue Ridge Blvd
Kansas City, MO 64134
www.hepcmo.org

Treatment Action Group
611 Broadway Suite 608
New York, NY 10012
www.treatmentactiongroup.org