At one point in her life, Tracey Sigler admits, the mere mention of human medical experiments would have probably triggered an immediate reaction.
Minority participation is vital
No way. No way was she going to be some sort of human guinea pig.
But she acknowledges that times have changed and so has she.
So when she saw an ad seeking volunteers for a study that could potentially help other women with a rare form of diabetes, she decided to sign up.
“I’m very comfortable,” she says. “It will help others and increase awareness.”
And that’s the point.
“Today’s standard treatments,” Dr. Lidia Schapira explains, “are yesterday’s clinical trials.” Schapira is an oncologist at Massachusetts General Hospital and an assistant professor at Harvard Medical School.
“Many of the treatments we take for granted are the results of clinical trials,” she continued. One example is the treatment for breast cancer. Schapira pointed out that, prior to research, women who are now candidates for breast-conserving treatment were subjected to complete removal of the breast.
At their most basic, clinical trials are research studies conducted to find an improved way to prevent, diagnose or treat a disease or condition.
Most everyone understands the necessity. They also understand the risks. And that’s when mistrust can enter the picture — often aimed not only at the research and its inherent risks, but also at those conducting the research.
It wasn’t that long ago — 1997 to be exact — when President Bill Clinton apologized for the federal government’s role in the Tuskegee experiment. Started in 1932, the 40-year study enlisted mostly illiterate sharecroppers in Alabama to participate in what they were told was a study on “bad blood.”
In reality, the study was on the ravages of syphilis. The men were left to suffer its consequences even when a suitable treatment became available.
The lingering mistrust still looms large. A recent study undertaken by Dr. Neil R. Powe details the split between blacks and whites.
Powe, of Johns Hopkins Medical Institutions, and his associates found that only 27 percent of blacks surveyed expressed willingness to participate in a cardiovascular drug trial, compared to 39 percent of whites.
According to the study, more blacks said they believed that doctors would use them as guinea pigs without their consent, that they would be asked to participate in research even if it were harmful, and that doctors would not fully explain the research to them.
More troubling was that more than half of the black respondents said that doctors had previously experimented on them without their consent. Only one-fourth of whites had a similar response.
The researchers noted that, after controlling for perceived risk and distrust, willingness to participate was not significantly different between blacks and whites.
The numbers are clear. The National Cancer Institute, for instance, found that between Jan. 1, 2003 and June 30, 2005, only 8 percent of blacks participated in research studies supported by the institute. Yet, incidence and death rates of cancer in blacks far exceed those in whites.
The egregiousness of the Tuskegee study is not debatable. Much damage was done. But not participating in clinical trials could be equally damaging.
When research is conducted on whites only, medical experts argue, doctors are forced to assume that the results are transferable to all people. But that is not always a correct assumption.
In a recent study, doctors found that black women with advanced and recurrent cervical cancer tolerated platinum-based chemotherapy better than white women participating in the same study.
“Everyone should be included in a clinical trial,” said Schapira. “When a group is excluded, that group loses.”
That is exactly what Tracey Sigler was thinking.
Three years ago, she was pregnant and developed gestational diabetes, a relatively rare disease that occurs in only about 4 percent of all pregnancies, and more frequently in women of color — blacks, Asians, Latinas and American Indian.
Although the exact cause of gestational diabetes is unknown, if left untreated or poorly controlled, it can cause long-term medical problems for both mother and child. Gestational diabetes increases the risk of heart disease after pregnancy.
Sigler was able to control her condition with diet; fortunately, she did not have to resort to insulin. But Sigler still had concerns. Though free of diabetes after the birth of her son, she was not completely out of danger — high blood pressure and other cardiovascular diseases run in her family.
For her, the decision to participate in the study conducted at Brigham and Women’s Hospital was not hard.
For what she hoped to gain, Sigler said, the requirements were minimal.
She fasted the night before and spent about five hours the next day undergoing tests at the hospital. The study consisted of an oral glucose tolerance test, fasting blood tests and a non-invasive blood vessel study.
The only discomfort she experienced was a slight headache from a nitroglycerin pill she was asked to take, but even that subsided quickly.
Not all trials carry risks or even an interventional treatment. Quality of life trials seek to improve the comfort and quality of life of patients and their caregivers.
Take Carmiletta Teasley, for example. Teasley, 49, volunteered for a 20-week program studying the impact of human touch on cancer survivors.
Yes — massage therapy.
She heard about the study through The Wellness Community, a support group at The Dimock Center, where it was described as a “unique opportunity for people with cancer and their caregivers.”
Sponsored by the National Cancer Institute, the study was designed to determine if caregivers could be taught simple touch and massage techniques to alleviate the discomfort suffered by cancer patients.
The massage “aroused my curiosity,” Teasley said. “It could be a gold mine.”
Her mind raced with excitement.
“If massage worked on my side effects of cancer, it might help diabetes as well,” she said. “My curiosity overcame any reservation I had.”
Teasley is still under treatment for sarcoma and melanoma.
In spite of her medical conditions, Teasley considers herself blessed.
The study required a caretaker to work with her, and she requested that to be her best friend — a cancer survivor herself.
Her friend could relate to many of the things Teasley was going through, which is why she agreed to work with her.
For the first part of the experiment, her caretaker read the Bible to her. “Both of us are very spiritual,” Teasley said. “Many people turn to their faith to see it through.”
After four weeks of reading the Bible, the massage sessions began. Her caretaker massaged her hands, feet and legs.
According to Teasley, head massages did the trick.
“Especially on a bald head,” she said.
For Teasley, the trial was a good thing. “I now have a means of alleviating many of the side effects of my illness,” Teasley said. “Now I know there is something that works.”
Even now she still resorts to massages to ease her discomfort.
Teasley is not through with clinical trials. The chemotherapy is not working and she is looking for other research at Dana-Farber Cancer Institute. She found another trial, but the decision was not easy.
“It’s a painstaking process,” she said, noting that she fully understands the risks involved with the new trial. “You need to understand the guidelines. You have to know what you’re willing and not willing to do.”
She also stressed the fact that a person has the right to pick and choose.
“It’s a personal journey,” she explained. “The decision can mean life or death. I’m not sure if I have an alternative.”
Lebaron Brown, 50, figured he had nothing to lose.
“For a lot of years,” he confessed, “I’ve felt lousy.”
But he ignored a slew of symptoms, even remaining in denial about the lump on his neck that continued to grow.
Finally, he went to the clinic for a check up, and, to say the least, it didn’t go well — he had Stage IV colon cancer and it had spread to his liver, lungs, kidney and brain.
That’s when his doctors at Boston Medical Center offered Brown a clinical trial.
“They explained everything,” he said. “They did an excellent job in making me understand. They warned me that, because of the extent of my cancer, they were going to hit me with a very powerful, fast working drug.”
He is still able to tick off the possible side effects — loss of appetite, nausea, vomiting, rash, hair loss, chills and fever.
He had them all.
But Brown is not complaining. His lump has disappeared.
“That was the first to go,” he said. “I was sick as a dog but it was working.”
Brown said he never had an issue with mistrust.
“I looked in their eyes,” he recalled. “They were sincere and concerned to help me. I trusted them. They laid it out to me and I signed.”
And as far as Brown is concerned, it was a good decision.
“I’m still here,” he exclaimed. “I feel better than I have in 15 or 20 years.”
|(Top) Tracey Sigler (left), shown with her son, Bryant, participated in a study to investigate risk factors associated with gestational diabetes, a rare disease that disproportionately impacts black women.
(Bottom) Lidia Schapira, M.D.
Assistant Professor of Medicine
Harvard Medical School
(Top) Lebaron Brown credits his survival to a clinical trial for his Stage IV colon cancer.
(Bottom) Carmiletta Teasley plans to enter a study for her cancer that is not responding to traditional treatment.