Advocates slam 'racist' drug trial
Advocates slam 'racist' drug trial
Schering-Plough defends hepatitis C test exclusion
Thursday, March 30, 2006
BY GEORGE E. JORDAN
Star-Ledger Staff
Two patient advocacy groups yesterday accused Schering-Plough of racial
discrimination for excluding African-Americans from a clinical trial of its new
hepatitis C treatment.
They claim African-Americans, classified as "hard to treat" because they
do not respond well to traditional hepatitis treatment regimens, were excluded
so the clinical trial would generate high success rates.
"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
Mobiliza tion Project, or CHAMP, who de cried "the racist exclusion."
The Kenilworth-based company said its new treatment is for patients who do
not respond to the standard combination therapy of interferon and ribavirin.
"It doesn't make any sense," said Bob Consalvo, a Schering- Plough
spokesman, of the advocacy groups' criticism.
He said there were scientific reasons for excluding African- Americans
from the Phase II clinical trial currently under way. That trial involves 300
patents worldwide to establish dosage ranges for the new protease inhibitor,
code named SCH 503034. He said African-Americans would be included in another
branch of the Phase II trail, which involves testing high dosages.
African-Americans, who make up a significant portion of the nonresponders,
are an important part of the $3 billion hepatitis market. About 4 million
Americans have been infected with hepatitis C, which is spread by contact with
blood. It can be transmitted to babies at birth and by drug addicts sharing
hypodermic needles.
For reasons researchers do not fully understand, a statistically
significant percentage of African-Americans do not respond to traditional
hepatitis C treatments. Further complicating the matter is that
African-Americans who contract hepatitis C tend to have other health
complications.
Brian Klein of the Hepatitis C Action & Advocacy Coalition said advocates
held a March 16 conference call with Schering-Plough officials, including
Clifford Brass, a top researcher.
"Schering-Plough has offered no valid safety reason for the ex clusion,"
Klein said in a statement. "It is clear to us that Schering-Plough chose to ex
clude an entire racial group from the study to achieve the best effi cacy
results possible on the road to marketing the drug."
Consalvo, who participated in the conference call, said Scher ing-Plough
scientists were concerned about the public perception of excluding
African-Americans from the Phase II dosing trials.
"It was something, at first blush, that causes concern," he said. "We
absolutely had the same concern."
After consultation with peer review boards and other hepatitis
researchers, he said, the drug maker concluded it was "more prudent and
scientific valid" to limit African-American participation until Phase III.
That's when the range of dosages established in Phase II of the clinical trial
can be tested to determine which is most efficacious treatment for the full
range of patient groups.
In a statement, Dillard, who is black, dismissed Schering- Plough's
explanation, and the addition of African-Americans to a high-dose test group.
"People of African descent are allowed into the trial as long as they are
not African-Americans," she said. "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."
George E. Jordan may be reached at gjordan@... or (973)
392-1801.
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