Surgeon and New Yorker staff writer Atul Gawande has a scary op/ed in Sunday's New York Times. As Gawande reports:
A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves.
The results were stunning. Within three months, the rate of bloodstream infections from these I.V. lines fell by two-thirds. The average I.C.U. cut its infection rate from 4 percent to zero. Over 18 months, the program saved more than 1,500 lives and nearly $200 million.
Great. You'd think hearty congratulations are in order for the researchers for finding a cheap easy way to save lives. Not so fast. The Feds have shut the program down. Gawande explains:
…the Office for Human Research Protections shut the program down. The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.
The Feds' ethics bureaucracy is treating such checklists as though they were experimental drugs being injected into the bodies of patients without their permission. It may be a failure of my ethical imagination, but I can't believe that just checking to see that you're doing what you're supposed to be doing anyway–preventing infections–is somehow unethical.
Whole Gawande op/ed here.