An article in a recent edition of the New York Times examines the struggle between treating patients responsibly, and gathering scientific knowledge through research.
Controlled testing of a melanoma drug called PLX4032 is at the center of this most recent debate. The study was designed as a traditional, randomized, controlled trial that enrolled half of the patients in the group to receive the study drug and half of the patients in the group to receive the standard chemotherapy treatment. The problem was that “the standard chemotherapy used in melanoma, dacarbazine, slowed tumor growth in 15 percent of patients for an average of two months,” while the study drug “had halted tumor growth in 81 percent of patients for an average of eight [months].”
Although considered the gold standard for proving a drug’s efficacy, such controlled trials raise many ethical questions. Is it researchers’ responsibility to collect accurate data, look out for patients’ best interests, or both? Is there a way that researchers can benefit the greater good and gather accurate, reliable data without submitting a large number of patients to a treatment that is considered unsatisfactory? What is the IRB’s role in reviewing this research and its consequences on subjects?