By Eric Sabo, Medical Writer, CBS Healthwatch
Bad Docs
In fact, withholding relevant information from study volunteers is a major source of trouble. Documents from the National Institutes of Health show that informed-consent problems accounted for 34% of government crackdowns on clinical trials over the past 10 years, making this the second leading reason why researchers were cited for violations. A similar pattern of bad advice is also alleged in several recent lawsuits.
"Patients think they're talking to a doctor, but they're really talking to an entrepreneur," says Alan Milstein, an attorney who represented Jesse Gelsinger's family and is now suing the University of Oklahoma for misleading subjects on the true nature of a cancer vaccine trial. "What we find in these cases is that even though the risks may be in the consent form, the doctor will say, 'Don't worry about it. This is just something our lawyers make us put in.'"
Such serious breeches of trust, many experts contend, are far more the exception than the rule. But some worry that these high-profile abuses may scare off patients and undermine legitimate efforts to find new treatments. US research has emerged from the Cold War days of secretly feeding radioactive oatmeal to a group of mentally handicapped children--one of several horror stories that came out of a 1995 investigation by the Department of Energy. Still, the current atmosphere of little white lies and questionable financial arrangements points to a deepening crisis.
Some key concerns: