Advocates slam 'racist' drug trial

[Guest guest]

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.

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."

E. Jordan may be reached at gjordan@... or (973) 392-1801.

http://www.nj.com/business/ledger/index.ssf?/base/business-0/1143701802297030.xml & coll=1