Word: patients
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...what they got, once they joined McGee's clinical trial, many patients say, was a different story. According to Mathias, more than a third developed severe side effects, including uncontrollable nausea, fevers, rashes, swelling and terrible headaches. Some thought the doctor's behavior was odd. While on the vaccine, one patient, Dawanna Robertson, discovered she was pregnant; she panicked when she recalled the warning on the consent form she had signed: "The potential effects of these drugs on the growing fetus...may include serious birth defects." Yet when she voiced her fears, Robertson says, McGee assured her that the vaccine...
...only get worse as the number of trials increases. According to CenterWatch, a patient information group that monitors clinical research, 80,000 clinical trials were conducted in the U.S. last year alone. Adil Shamoo, a bioethicist from the University of Maryland School of Medicine who sits on the National Human Research Protection Advisory Committee, estimates that some 20 million people were enrolled as research subjects last year--three times the number a decade...
Both DeGette and Kennedy endorse the idea of accrediting IRBs. But they are split on whether accreditation should be mandatory. So far, Kennedy is saying yes. DeGette, who has championed patient protection in part because the University of Colorado was severely sanctioned by OHRP in 1999, thinks a voluntary system would, paradoxically, protect patients better. "The whole point of accreditation," says DeGette, "is to encourage research institutions to reach for a higher bar, to go above and beyond the minimum requirements...
Vieweg, who is attempting to develop vaccines for prostate and kidney cancer using a patient's own white blood cells, is acutely aware of the heartbreaking dilemma posed by clinical trials. "We make it clear that we cannot promise cures. We make it clear that there is the possibility of adverse effects. We tell them the benefit is probably to the next generation of patients. And yet we know these patients are clinging to the hope that this will have an impact on their tumor." How can they...
...fact, it is clear that many patients derive benefit just from taking part in a trial, independent of the effectiveness of the drug they are testing. That's because most trials involve multiple visits and substantial doctor-patient interaction. "Besides a clinical improvement," says Vieweg, "the second best thing you can give patients is the feeling that they are being taken care of, that you are interested in the particulars of their disease, their progress and what they have to cope with in their daily lives. It's an incredibly important aspect of what...