My Experience

Tracy

Age 46
Los Angeles

Tracy, a Los Angeles wife and mother of four, was diagnosed with lupus in 1987 and was put on multiple treatments including steroids, chemotherapy and pain medication. But she began to feel the way many patients feel after years of coping with the disease and its treatments: tired, in pain and frustrated that none of her medications were working anymore. In fact, she felt her condition had become worse and that she was running out of options.

As her discouragement increased, her physician, Daniel J. Wallace, MD, suggested that she enroll in a clinical trial. Like Tracy, many people with lupus are confronted with the decision about whether or not to enroll in a clinical trial.

Participating in a trial was scary at first for Tracy: “The idea of being a human guinea pig didn’t excite me; to be honest, it terrified me.” Despite her fears, Tracy agreed to be considered for the trial “to take control, feel better and be healthy enough to care for my family.” She also had another compelling reason to take part in furthering the science of lupus. “My 8-year old daughter is beginning to show lupus symptoms. If it turns out that she has lupus, I want her to have better medications than the drugs currently available, which can be very toxic,” Tracy said.

“My first appointment was to determine if I was eligible. The trial nurse had me fill out paperwork—a 29-page document—and drew many, many vials of blood,” Tracy recounted. “After reading the documents, I found out that the trial involved four groups of patients, with three groups getting the study drug, but in different dosages. My odds of getting the real thing were a bit better in this trial, not the normal 50/50 of a control group versus placebo.”

Clinical trials offer many benefits to patients, including access to new research treatments before they are widely available, and expert medical care at leading health care facilities. However, enrolling in a trial is an important personal decision, and involves a careful assessment of the benefits and risks.

There may be risks, both known and unknown, when taking experimental therapies. Side effects to treatments can be serious or unpleasant. In addition, a treatment intended to improve a condition may deliver no beneficial effects at all.

Tracy advises patients who are considering participating in a clinical trial to take several important steps:

• Speak with your own physician (not just those conducting the trial); you’ll need help
  understanding the complex information that is provided, including many legal disclaimers you will want to have interpreted.
• Read as much as you can about the status of the trial, the compound under investigation, the company conducting the trial.
• Ask questions: Are there results from any human trials yet?; If so, what were the side effects?; How are these patients doing?

In addition, Tracy advises enlisting an “advocate” in the process—a family member or close friend, who can help you review the issues as they arise.

It has been seven months since Tracy began the trial, and her experience has been positive. She has had minimal side effects and when the trial is completed, she expects to continue on the drug.

Tracy underscores that “trial patients should not have unrealistic expectations and since clinical trials involve a relatively small segment of the patient population, problems may, indeed, surface later on….this drug still may not be the cure we’re all hoping for, but I wanted to take a leap of faith.”