IN 1998 BITSY BRUMAGE, one of my friends in San Antonio, had a recurrence of breast cancer, the same disease that had killed my mother five years before. Unlike my mother, Bitsy decided to participate in a clinical trial to test a new cancer drug she believed had a good chance to extend her life. I admired Bitsy’s courage, so different from my mother’s unwillingness to seek aggressive treatment: Mom wouldn’t even consider seeking a second opinion, much less volunteer for experimental drugs. She was afraid of offending her doctor. To my mother and her generation, breast cancer was a death sentence. To Bitsy and women of my generation, it’s a long-running emotional and scientific riddle. I think of these human volunteers who take part in clinical trials as the Good Rats—subjects in the great experiment to get new drugs and treatments out of the research lab and onto the market and, ultimately, solve the riddle of breast cancer.
The recurrence was a surprise—but so had been the original diagnosis. In the fall of 1992, Bitsy was only 44 years old and had no reason to see trouble coming, no family history of breast cancer. She and Max, her husband, had two sons, 9-year-old Jesse and 3-year-old Lee, who was the same age as my son, Tyler. One day Bitsy, who then worked as a psychologist at the Texas Headache Institute, in San Antonio, felt a small, fat lump in her left breast. She went to her doctor and within a few weeks had mastectomies on both breasts. The cancer had already spread to one lymph node. In the spring of 1993, she took six cycles of chemotherapy and a round of radiation. The prognosis was good: a 70 percent chance that the cancer would not recur in five years.
By 1998 cancer was no longer just Bitsy’s disease; it had become her full-time job. She and four other women in her breast cancer support group organized the San Antonio affiliate of the Susan G. Komen Breast Cancer Foundation, which has contributed $3.2 million in the past seven years for local services such as breast cancer awareness. But in April 1998, a week before the first Komen Race for the Cure in San Antonio and five and a half years after her original diagnosis, Bitsy experienced severe back pain. Her doctor ordered a bone scan. The cancer had spread to her lower spine. Nonetheless, on the morning of the race, Bitsy showed up early at Alamo Stadium, at Trinity University, to help register the 1,800 walkers, joggers, and runners and see them off.
It was Jesse’s freshman year at Alamo Heights High School. He joined the drum line in band and soon became its star. Tyler and Lee were in the third grade, and that particular spring we were consumed with Little League tryouts. Many afternoons after school Bitsy and I sat in the stands at Alamo Heights Little League games watching our sons swing at balls, run bases, and catch pop flies. In those moments, buoyed by the sun-splotched green field and windy blue skies and the pleasure of observing our young sons at play, it was hard to believe that the world was not picture-perfect and full of life.
By then, several of Bitsy’s friends had died of breast cancer. Some had participated in clinical trials both as a way to save their own lives and to help others. She resolved to do the same. Bitsy wanted to make meaning out of her cancer. It was personal: Bitsy versus the cancer. Even if she died, she wanted to have contributed to finding a cure for the disease. Dr. Fred Hausheer, a professor of medicine who specializes in oncology, spoke to Bitsy’s support group and explained how difficult it is to get promising new drugs approved. The timetable is ten to fifteen years from the research lab to the market, and the average cost of producing a new cancer drug now approaches $1 billion. Research grants are hard to come by, especially if an experimental drug doesn’t have obvious market potential. At this point, Bitsy was already undergoing more aggressive treatment—a strong form of chemotherapy (six cycles of Taxol) as well as an antibiotic and another cancer drug—but she worried that the treatment wasn’t enough.
The leading center for cancer trials in Texas is M. D. Anderson Cancer Center, in Houston. In 2004 more than 12,000 patients participated in trials at the hospital, the largest such program in the nation. But Bitsy instead found a trial of a new drug at the University of Texas Health Science Center at San Antonio so she wouldn’t have to travel out of town and be away from Max and the boys.
After gathering the information, Bitsy and Max sat the two boys down in the living room to explain the details. Bitsy told them that clinical trials were the only way that a cure for cancer would ever be found. The trials would allow researchers to gain information on benefits, side effects, and applications of new drugs. She described the research phases of trials. Phase I involves a small number of people and is generally the most dangerous. Patients are given a new drug that has never been used in humans in an effort to determine the proper initial dose levels. If the results are promising, the drug moves to phase II to determine more-refined dose levels and then to phase III, which involves hundreds, maybe thousands of people. The goal is to compare the new drug with the best-known drug on the market. Bitsy would be involved in a phase III trial of a new drug called Faslodex, an antihormonal treatment, to compare its effectiveness with Arimidex, the older, standard treatment. If Faslodex proved more beneficial, it would be considered by the U.S. Food and Drug Administration for approval.
Most people view clinical trials as a last resort. Bitsy saw her trial as a way to get better care and closer monitoring—not just by her own