Rare Cancer Treatments, Cleared by F.D.A. but Not Subject to Scrutiny

December 4, 2013

New York Times - When federal regulators permitted the sale of an unproved device that uses intense heat to combat cancer, they did so for a compelling reason, to give hope to some women desperately ill with cervical cancer. Over the next two years, however, the few hospitals that purchased the $500,000 device did not take part in a study of patients that the manufacturer agreed to perform as a part of the machine’s approval. Cancer experts also said they were surprised that the Food and Drug Administration had approved the machine in the first place.

New York Times article