Test For All, Cure For All

Thursday, April 20, 2006

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


Dr. Debra B Birnkrant April 20th
2006
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
http://www.champnetwork.org/

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

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

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

Saturday, April 08, 2006

Open Letters: Questions on the exclusion of African-American patients in study P03659 (NCT00160251)

Friday, April 07, 2006

Open Letters: Follow-up to the March 29 letter on Schering-Plough study P03659 (NCT00160251)

No Blacks Allowed? A Drug Trial Comes Under Fire
by Kellee Terrell

April 5, 2006—Charges of discrimination and bad science are dampening excitement at Schering-Plough this year about a whole new type of drug that might treat hepatitis C virus (HCV) sufferers who don’t benefit from the current two-drug regimen.

“It is totally unacceptable,” says Tracy Swan of the New York–based Treatment Action Group (TAG) about the way the pharmaceutical company purposefully excluded African Americans from the first stages of clinical trials on its new HCV protease inhibitor, SCH 503034.
“Could you do that with women? Gays and lesbians? The risks and benefits of participating in research should be divided equally.”

Schering-Plough is adamant that its recruiting practices are sound—and FDA-approved. Spokesman Robert J. Cansalvo argues that because black people are known to respond poorly to one of the drugs that SCH 503034 is being tested with, including them as subjects in early, smaller trials would have been unnecessary. “It’s a question of timing when to include them,” he says, pointing out that African Americans will definitely be in the next round of trials—in large enough numbers to measure any race-related problems or benefits.

Some HCV experts and activists agree that the SCH 503034 trials are proceeding just fine and that Schering-Plough should be left alone on this minor technicality so that this valuable product might move closer to market. But critics like the Community HIV/AIDS Mobilization (CHAMP) and Hepatitis C Action and Advocacy Coalition (HAAC) see a disservice to both African Americans and research, especially given that HCV is three times more common among them than whites; cure rates are lower for African Americans on the existing meds; and they are more susceptible to complications of HCV infection such as liver cancer, end-stage liver failure, cirrhosis and death.

“We would understand if the exclusion was about safety,” says HAAC’s James Learned. For instance, he says, he has no problem with Schering’s decision not to include HIV positive subjects in these trials for fear that their HIV meds might react with the experimental drugs—even though hepatitis-related liver disease is the leading cause of death for Americans with HIV.

“Safety does not seem to be the issue here,” he says, but rather “buzz” and “making your group look good.”

Consalvo finds these criticisms “ridiculous.” He says, “We are committed to finding help for all African Americans who have hep C.” Some activists join Schering-Plough in worrying that CHAMP and HAAC might have unduly alarmed the African-American community. Racial questions about prescription drugs and even the origins of some diseases hardly fall on deaf ears. According to a University of Houston study reported last month in the Journal of Acquired Immune Deficiency Syndromes, 30% of Texas African Americans and 22% of Texas Latinos believe HIV is a government conspiracy to kill minorities.