STEVE INSKEEP, host:
This month's issue of a medical journal, The Annals of Emergency Medicine, contains a report of a promising new treatment for people with serious head injuries, and how that study was done may be just as groundbreaking as what it shows.
NPR's Joanne Silberner reports.
JOANNE SILBERNER: Several years ago, Dr. Art Kellerman ran the emergency room at Grady Memorial Hospital in Atlanta, which has a sophisticated trauma center, and he saw a lot of patients come in with brain injuries as a result of car accidents, falls or other blows to the head. Brain injuries kill 50,000 Americans a year and he couldn't do much to help.
Dr. ART KELLERMAN (Chairman, Department of Emergency Medicine, Emory University): We really don't have anything in our toolbox that we can give a patient that makes a major change in their course after a brain injury.
SILBERNER: Studies on animals showed that the female hormone progesterone might help. It's a steroid, so it reduces swelling. It protects brain cells and it doesn't feminize men. But still Kellerman was worried about how people might react to what he wanted to try.
Dr. KELLERMAN: This is a female hormone being used to treat a condition that occurs primarily in men. Men get hurt critically much more often than women do. And so we were concerned there might be a public reaction or a public backlash. What in the world are they doing at that hospital? Why are they giving female hormones to young men for a brain injury? What's this all about?
SILBERNER: And indeed it sounded strange to Reverend Timothy McDonald, pastor of the First Iconium Baptist Church in Atlanta and president of Concerned Black Clergy.
Reverend TIMOTHY MCDONALD (Pastor, First Iconium Baptist Church, Atlanta; President, Concerned Black Clergy): Well, in the black community you just don't mix male and female hormones. And I am not a medical person and it just did not sound right to me.
SILBERNER: And Kellerman notes there was a second challenge.
Dr. KELLERMAN: There were real political risks in trying to do a study like this in a hospital that historically primarily served poor disadvantaged patients, an awful lot of whom are African-American in the American South.
SILBERNER: The worst legacy - the Tuskegee experiment, where, in the middle of the last century to see what would happen, poor black men with syphilis were allowed to go untreated when there was a safe and effective cure available. So Kellerman made two decisions about how his team would do the research. They would ask family members for permission, even though it might take valuable time to find family members after an accident. The second decision: not to do the experiment in Atlanta if local leaders didn't want it.
Dr. KELLERMAN: Some people said, what in the world are you doing? You're going to a community activist and you're saying, look, if you don't want to do this study, tell me; we won't do it. And my response was, if they don't want to do the study, they're going to shut it down whether I give them the power or not.
SILBERNER: Kellerman phoned up Dr. Gerald Durley, senior pastor of Providence Missionary Baptist Church in Atlanta, and asked his opinion.
Pastor GERALD DURLEY (Senior Pastor, Providence Missionary Baptist Church, Atlanta): Always in the back of my mind: Are we doing something that can alleviate pains, injury and our death?
SILBERNER: He advised Kellerman to get input from others in the black community. So Kellerman organized several meetings at a downtown church. Among the attendees were Durley and McDonald.
Pastor DURLEY: So I was already impressed with the idea that whoever was doing this study thought enough to talk with people in the community, to talk with religious leaders. I have never before, nor since, been approached by anybody conducting such as study.
SILBERNER: Kellerman talked to Hispanic leaders and the local brain injury support group. All gave him the go-ahead. Pastor Durley.
Pastor DURLEY: What reduced my skepticism was the man Dr. Arthur Kellerman. I knew him. I saw him stand up when we had racial seminars and how he stood up and was extremely objective in his articulation of relationships between people. So the credibility of the person certainly initially endeared me to the project.
SILBERNER: And the other convincing factor - the lack of an effective treatment. So Kellerman and 17 others from Emory University and Morehouse School of Medicine went ahead and tried the progesterone. Thirty percent of the people who received a placebo died in the first month compared to just 13 percent of those who received progesterone. Kellerman had answers to his questions about safety and effectiveness.
Dr. KELLERMAN: We know what this therapy looks like, at least based on the first 77 patients that received it, and we have some pretty exciting evidence that it may be effective as well. But the definitive answer, the final word, will have to wait until we can conduct a larger study in multiple trauma centers with a much larger population of patients.
SILBERNER: Kellerman says his group is working on getting funding for a larger and more definitive study.
Joanne Silberner, NPR News. Transcript provided by NPR, Copyright NPR.
