The Good Rats
The women of my generation see cancer not as a death sentence but as a riddle to be solved. And thanks to clinical drug trials, we’re solving it.
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 doctor but by the staff at the UT Health Science Center as well. Before the trial began, she met with members of the research team, who explained the benefits and risks and told her she could leave the trial at any time. The cost was covered by her insurance company and the manufacturer of the drug. Once the trial began, she received one pill a day that was either Arimidex or a placebo and an injection once a month that was either Faslodex or a placebo. One of the two treatments had to contain an active drug. Naturally, Bitsy wondered if she was getting Faslodex. She and her research nurse, a friendly woman who never failed to ask about Bitsy’s boys, speculated on it every month.
In October 2000 Bitsy’s doctor and the research team found that her cancer had progressed again. She asked which drug she’d been taking: Arimidex, the old one, or Faslodex, the new? It turned out she’d been taking the old one. But Bitsy didn’t give up. The following year, she participated in another small trial, and this time she got Faslodex. Not long after that, Faslodex was approved by the FDA. “I not only helped myself get new treatment, I helped get the drug approved,” said Bitsy. “It felt really rewarding to be part of the solution.”
By this time, Bitsy and Jerry Worden, one of the other founders of the local Komen Foundation affiliate, started a second organization, the Clinical Trials Task Force of San Antonio, to encourage both physicians and patients to participate in trials. Six years earlier, when she was only 39, Jerry had been diagnosed with inflammatory breast cancer, a rare and aggressive form of the disease. The first hint that anything was wrong was a tiny drop of blood from her nipple. A few mammograms later, Jerry learned she was in a late stage of breast cancer and had only a 15 percent chance of surviving five years. “I remember levitating,” recalled Jerry. “I just mentally left my body. My girls were only four and six, and there I was, faced with an eighty-five percent chance of dying before either of them would be in high school.”
After her diagnosis, her doctor told her the cancer needed to be attacked with repeated rounds of chemotherapy to contain it. Jerry balked. She wanted a mastectomy first. “I want the cancer out of my body,” she told her doctor. The doctor showed Jerry the results of a clinical trial done in the early nineties at M. D. Anderson on women who had inflammatory breast cancer. One group of patients had chemo first; the other had mastectomies first. The group that had had chemo first had better survival rates. As a result, Jerry put off the mastectomy until after she had had chemo. “If those brave women hadn’t participated in that trial, I wouldn’t be alive right now,” Jerry said.
Consequently, in 2000, Jerry volunteered to be a Good Rat. She was one of 5,187 women who participated in a Canadian-led international clinical trial for a drug called letrozole. Jerry had taken tamoxifen, the standard treatment for blocking estrogen to the tumor, for five years. After five years, though, tumors become resistant to tamoxifen. Jerry joined the trial at the Health Science Center. Like the other women, she received a pill a day—either letrozole or a placebo, because there was no alternative treatment. Two years later Jerry’s trial was stopped early. Researchers had discovered that the women who were taking letrozole had a reduced risk for recurrence. Women who had been on the placebo were immediately offered letrozole. As it turned out, Jerry had been given the drug, not the placebo. Eleven years after her diagnosis and five years since the trial, Jerry’s cancer is in remission.
Bitsy’s cancer continues to be what she calls “slow moving.” In recent years, she has had both bone and liver progressions, which have responded well to treatment. All the drugs that Bitsy now takes were not on the market when she was first diagnosed, the year before my mother died of the disease, and all Bitsy’s drugs have been approved as a result of clinical trials. If someone had told me thirteen years ago that Bitsy would still be alive and going to baseball games, band fundraisers, and Parent Teacher Organization meetings, I wouldn’t have believed it. Jesse is in his last year of college at Texas Tech University, and Lee, like Tyler, is a sophomore at Alamo Heights High. Jerry’s daughters, Kelly and Kimberly, are there too.
Between 1990 and 2001, the mortality rate for women with breast cancer declined by 2.3 percent annually. When my mother was diagnosed, breast cancer was indeed a death sentence. Now, thanks to people like Bitsy, Jerry, and the other Good Rats, the whole conversation has shifted from how to die of breast cancer to how to live with it. “Some people think clinical trials are an exercise in false hope,” said Bitsy. “If you ask me, hope is hope.”