Earl Wright insists the government is being irrational by insisting he prove the simple gadget he invented will really help women detect lumps in their breasts.
"The American woman is not so stupid that she doesn't know whether it works," Wright said. "They'll return that pad in a minute if it doesn't work."But a panel of outside scientists told the Food and Drug Administration on Thursday to make Wright prove that his Sensor Pad won't mask lumps that women might feel with their fingers alone.
They told the inventor how to do that, outlining a series of studies that the National Cancer Institute's Dr. Barnett Kramer said could be performed in "months instead of years."
It was the latest twist in Wright's nine-year battle to sell his Sensor Pad, a layer of silicone between two sheets of plastic that Wright says acts as a "dry lubricant" to help women detect tiny lumps in their breasts.
Breast cancer strikes 180,000 American women a year and kills 46,000. Early detection is crucial to survival, so all women are advised to examine their breasts every month for lumps.
But the friction of dry skin makes tiny lumps difficult to detect, so many women examine their breasts in the bath, where soap and water eases the friction.
Wright says his Sensor Pad does the same thing, only more con-ven-ient-ly.
"I feel like it saved my life," said Mary Gorman of Chevy Chase, Md., whose doctor could hardly feel the lump she discovered using the Sensor Pad - one a mammogram four months earlier hadn't detected.
Just owning the pad is a reminder for women to check their breasts, added Illinois state Sen. Penny Severns, who found a small cancer in July but thinks the pad might have helped her find it earlier.