"This argues that we need a way of evaluating technologies before we put them into practice," Fenton said. "The government has a huge stake in this. And once the train leaves the station, it's difficult to call it back."
In the current review, Fenton suggests that intense lobbying by manufacturers of the technology, combined with the politically volatile issue of breast cancer screening, resulted in fast-track approval by the government of Medicare coverage of the device. He also argues that industry representatives were better able to market the device, which require a large capital investment of over $100,000, after providers were assured their costs would be reimbursed by the government insurance program.
In an accompanying commentary in the same issue of the Archives, Karla Kerlikowske, professor of medicine, epidemiology and biostatistics at UC San Francisco, says health-care providers and others cannot presume that newer technologies are better than existing ones.
"Health-care providers should not adopt new technologies without first demanding scientific evidence beyond that required for FDA approval," she writes, adding that such evidence should include not just clinical benefits, but also important associated harms and whether benefits outweigh those harms.
|Contact: Dorsey Griffith|
University of California - Davis - Health System