Sulmasy, senior author and a professor of medicine and ethics at the University of Chicago. “It’s the Lake Wobegon effect, ” said Dr. Others have been more reassuring, noting that patients are driven by a sense of altruism and a desire to help others who may one day suffer from the same disease. Some research on patient motivations has had disturbing ethical implications, indicating that patients may never fully understand the purpose of trials, despite explanations by the researchers. A major part of the debate has focused on the motivations of patients who participate. Her tumor never responded to the experimental treatment.įor almost four decades, researchers and patient advocates have debated the ethics of informed consent in early-phase clinical trials, studies that test only toxicity and dosing and offer little, if any, therapeutic benefit to those enrolled. I remembered her words a little over a year later when I heard she had died. And knowing what we did about the extent of her disease, it was hard not to convince ourselves that optimism, even if based on somewhat false hopes, had to be helpful for someone in her position. None of us wanted to deflate her sense of hope. But we were also hesitant to probe any further. She seemed to understand the study, and it was hard not to be in awe of her courage and selflessness. We all fell silent when she said those words. I would do anything for a little extra time with my children.” Then, voice lowered, she added: “I’m a mother. “I’ve been through this before,” she said to us as she signed the papers. The woman nodded and waved her hand for the consent form. Like other such trials, it would test only for toxicity and the maximum safe doses of the experimental drug generally fewer than 5 percent of patients ever benefit from such early trials. “Haven’t we talked about this enough?” she said smiling and nodding gamely as the head surgeon explained once more that because this was an early-phase trial, it would benefit research but was not likely to be of any therapeutic help to her. On the evening before her operation, she joked with the surgical team and shook her head when we asked if she had any more questions. This time she would participate in one of the earliest studies of a brand-new drug, a Phase I clinical trial, and would have to undergo major surgery before taking the experimental drug. Nonetheless, when her cancer began growing again, she eagerly applied for a third study. She had endured countless hospitalizations, serious bloating, a punctured lung, overwhelming fatigue and two nearly intractable infections. Her tumor had responded slightly during one of those studies, but slowing the pace of its growth had come at a significant price. By the time I met her, she was already the veteran of two clinical trials at the center. Known for her cheery disposition she reminded the doctors and nurses of a brunette Cathy Rigby she had melanoma that had spread through her body despite efforts to halt its growth. One of the patients was a woman in her late 30s, a mother of three. Every week, patients with rare diseases and cancers that had not responded to standard therapy arrived from all over the country, eager to try something new, even if the efficacy of the treatments had not yet been proven. As a medical student and later during my residency, I trained for some time in a medical center known for its research and clinical trials.
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