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Wednesday, March 29, 2006

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

An open letter to Schering-Plough:

I am writing to inquire about the study design of your phase 2 trail of the drug SCH 503034 in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis. According to clinicaltrials.gov, this trial excludes, among others, "patients with cirrhosis, co-infection with Hepatitis B or HIV, and African-American patients." As a geneticist and bioethicist, I have difficulty understanding why African-American patients are being excluded from this trial, particularly since that is the only ethnic group specifically excluded.

Excluding African-Americans will not lead to greater genetic homogeneity as 85% of genetic diversity is found within population groups. In addition, genetic, anthropological and other data show that individuals and populations vary along worldwide gradients rather than clustering into distinct "races."

Social and biological scientists have raised numerous concerns about the difficulties faced in defining a particular ethnic group, with "African-American" being particularly contentious. How are you defining "African-American" in your trial? How does your definition relate to the medical and biological phenomena being studied in the trial?

If you are excluding African-Americans for social or other nonbiological reasons, it would be useful to specifically define those exclusion criteria. That information could be used to exclude non-African-Americans who do meet the exclusion criteria, and include African-Americans who do not and otherwise qualify. Does your full-length protocol define such criteria for which 'African-American' is presumably used as a proxy? If so, are there reasons why this information is collapsed into the term 'African-American'?

The National Institutes of Health Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research states that
"women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant Institute/Center Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research."
Although your work is not supported by the NIH, I and others would like to know your compelling reason for excluding African-Americans.

Given the benefits and risks associated with participation in clinical trials, it is critical that only relevant criteria are used to exclude and include participants. I have called the Schering-Plough office at 908-298-7409 to raise these questions and concerns and look forward to your prompt reply. Thank you for your assistance in this matter.

Sincerely,

Karama C. Neal, PhD MA

4 Comments:

Blogger Karama said...

Earlier today I received the following email. If you email me, I will forward you the PDFs of the press release and background information from the Community HIV/AIDS Mobilization Project and Hepatitis C Action & Advocacy Coalition. I'll let you all know if I hear anything more or different from Schering-Plough.

Subject: Schering-Plough Bans African Americans from Early Hepatitis C Clinical Trial

PRESS RELEASE from Community HIV/AIDS Mobilization Project (CHAMP) and Hepatitis C Action & Advocacy Coalition (HAAC)
For immediate Release:March 28, 2006
Contact: James Learned, (917) 620-0349, James_Learned@prodigy.net or Judith Dillard, (817) 570-9296, msjdillard@yahoo.com

SCHERING-PLOUGH BANS AFRICAN AMERICANS FROM EARLY HEPATITIS C CLINICAL TRIAL

In an egregious and! cynical tactic to make a drug in development look as good as possible, an entire racial group has been explicitly excluded from the clinical trial of an experimental drug. Schering-Plough Corporation has banned African Americans from participating in the dose-finding study of its experimental drug, SCH 503034, for the treatment of hepatitis C virus (HCV).

We demand that Schering-Plough end this unethical and baseless exclusion.

"Schering-Plough has offered no valid safety reason for the exclusion," said Brian Klein of the Hepatitis C Action & Advocacy Coalition (HAAC), who participated in a call with company representatives on March 17. "Compelling safety concerns would justify such an exclusion, but the company provided only vague comments that this was an 'efficient' way to develop the drug. It is clear to us that Schering-P! lough chose to exclude an entire racial group from the study to achieve the best efficacy results possible on the road to marketing the drug."

Over four million Americans have been infected with HCV in the United States, and HCV infection is as much as three times more prevalent in African Americans than in whites. Complications of HCV infection, cirrhosis, liver cancer, end-stage liver failure, and death, appear to be more common in African Americans. Studies show that, in general, African Americans have lower response rates to current HCV treatment compared to other racial groups. New treatment options are urgently needed for this population. In these studies, African Americans did not experience side effects or safety risks that were any more severe than those of other racial groups.

Phase 2 studies test different doses of an investigati! onal drug to find one that is within acceptable safety limits for further study. Phase 2 studies also provide crucial safety information and sometimes suggest how effective the drug might be. Schering-Plough, insists on excluding African Americans from participating in the Phase 2a study of SCH 503034. The company has agreed to allow a few African Americans into a recently added, higher drug dose arm of the study but will not integrate African Americans into the other study arms.

The SCH 503034 study includes safety criteria using laboratory tests and side effect monitoring to ensure that no participants enter or continue in the study if their health status is outside the acceptable ranges or if they are co-infected with HIV or hepatitis B or have advanced liver disease such as cirrhosis. HAAC members agree that these safety criteria are appropriate but assert that excluding anyone from participating in the trial due to race is inexcusable.

"The bottom line is that African Americans have been left out of this study to make the drug look good," said Judith Dillard of the Community HIV/AIDS Mobilization Project (CHAMP). "This is not about protecting people's health or even genetics, in fact, people of African descent are allowed into the trial as long as they are not African Americans! My community needs equal access to early research so we can find treatments that work for us, not just a few token people brought in later for the high dose arm to try to cover up this racist exclusion."

March 29, 2006  
Blogger Karama said...

You may want to check out this article from the NJ Star Ledger.

Also, I called the SP Clinical Trials Registry Call Center and specifically asked if they has a definition for "African-American". 'If my parents are born in African can I participate even if I was born in the US? What if I was born in Africa but now am an American citizen?" They replied "We don't have that information" and directed me to a study site. My call the the study site has not yet been returned.

March 30, 2006  
Blogger Karama said...

You may want to check out this full-length article in the NJ Star-Ledger: "Race and medicine: Beyond black and white: Dispute between AIDS advocates and Schering-Plough scientists highlights conflicts in research" by George Jordan, which appeared on Sunday, April 30, 2006.

May 01, 2006  
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