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Thursday, April 20, 2006

A Response to Schering-Plough's Decision of African American Exclusion

Dr. Debra B Birnkrant April 20th
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.

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

Harm Reduction Coalition
22 West 27th Street, 5th Floor
New York, NY 10001

Hepatitis C Action and Advocacy Coalition (HAAC)
53 Divisadero Street
San Francisco, CA 94117-3210

Hepatitis C Multicultural Outreach
10603 Blue Ridge Blvd
Kansas City, MO 64134

Treatment Action Group
611 Broadway Suite 608
New York, NY 10012


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