Researchers push for minorities in drug trials

By Timothy Pratt

Thursday, Feb. 9, 2006 | 12:30 p.m.

A clinical trial for a drug to treat congestive heart failure conducted in the early 1990s left researchers with little to be happy about.

The drug showed little success. But researchers then tried something different: They tested it only on black patients and found a dramatic turnaround.

The drug, BiDil, was approved last year by the FDA and is being called the first "ethnic" drug because it is marketed to black patients.

Troy Odynski, president of Clinical Research Center of Nevada, a company that conducts studies of new drugs for pharmaceutical companies, recounted the tale in his Las Vegas office to explain why his company and many others nationwide want to include more minorities in clinical research.

Historically, for any number of reasons, minorities haven't participated in the trials, which means that the drugs haven't been fully tested against a cross-section of society. Researchers could be missing some trends.

Darlene Steljes, chief executive officer at the Clinical Research Center of Nevada, is determined to include more minorities in the studies, whether that means overcoming distrust, or just getting the word out more.

Or changing her company around to include more minority doctors and recruiters, as well as translating materials such as consent forms into Spanish.

"Guess what? I'm leaving out 40 percent of the population if I don't use minorities," Steljes said, referring to census estimates of the valley's population that recently placed the total percentage of Hispanics, blacks, Asians, American Indians and Hawaiians at 44.1 percent.

The studies, which are part of an approval process that averages eight to 10 years to complete, help determine whether the Federal Drug Administration will approve a new drug.

Her company is not the only one facing the issue. It has been the subject of recent research journal articles, and large organizations such as the National Cancer Institute, have put millions of dollars into increasing minority participation in medical studies.

Locally, the Nevada Office of Minority Health, an agency created by the 2005 Legislature, has put the issue on its radar screen. Director Larry Gamell has put Steljes together with people who could help her get the word out via radio, community meetings and health fairs.

Steljes said 90 percent of the approximately 2,000 participants in her company's 60 annual studies are white. Gamell and others have told her that one reason for that is a lack of trust.

"I was told, 'We're very suspicious,'" she said. "They mentioned the Tuskegee experiments."

The infamous Tuskegee study, which ran from 1932 to 1972, involved 399 black men with syphilis and 201 without the disease in Macon County, Ala. For 40 years the federal government gave the men free medical exams, free meals and burial insurance. But they never gave them treatment.

News reports uncovered the study's problems in 1972. A federally appointed panel concluded later the same year that the study was "ethically unjustified," and it was stopped. A lawsuit then resulted in the government paying survivors more than $9 million and giving them free medical care.

The largest minority community in the valley is Hispanic, estimated at about 25 percent of the local population.

Steljes said she was lucky to run across Gloria Regalado four months ago, who not only is Hispanic, but speaks Spanish and English well, having been an interpreter for attorneys.

In addition - and perhaps most importantly - she had gone through a medical research study herself, for a drug to control blood sugar levels. In 2002, when Regalado discovered she had diabetes, she didn't have health insurance. A friend told her about a study being done. She enrolled, stayed with it for a year, and learned how her diet and other factors such as stress affected her blood sugar.

Now she works for the Clinical Research Center of Nevada as a recruitment coordinator and talks to groups in the Hispanic community at least three times a week.

What does she find? "They don't know what clinical research is about," she said. "They don't see it as a benefit. But when they see that I benefited from it, they want to participate."

Regalado's experience would seem to be supported by a recent paper titled, "Are Racial and Ethnic Minorities Less Willing to Participate in Health Research?"

Published in PLoS (Public Library of Science) Medicine, a peer-reviewed monthly journal, the article's authors reviewed 20 studies with more than 70,000 participants.

It concluded that there were "very small differences in the willingness of minorities, most of whom were blacks and Hispanics in the United States, to participate in health research compared to non-Hispanic whites."

In other words, increasing minority participation in clinical research studies may be as much a question of getting the word out as it is of overcoming distrust.

Either way, Odynski said, his company - and hundreds more nationwide - are facing "a whole new ballgame," as more pharmaceutical companies ask for information on the race and ethnicity of participants.

Steljes noted that the newness of their task also had a certain familiarity to it.

"People - no matter what color, race or ethnicity - want to know, 'What benefit is this going to bring to me?' That's human nature."

Timothy Pratt can be reached at 259-8828 or at [email protected].