Did Ethical Standards Slip In Disc Trials?
Researchers Had Financial Interest in the Subject of Their Study
The Food and Drug Administration said last month that it is investigating whether several orthopedic surgeons failed to properly disclose their financial investments in the manufacturer of an artificial spinal disc that the FDA approved in 2006. The surgeons, who were conducting clinical trials that ultimately led to FDA approval of the ProDisc-L lumbar replacement disc, were also investors in a venture capital fund that invested in the development of the product. As investors, the physicians stood to gain financially from the success of the clinical trials. "We are looking at the issue," says Karen Riley, a spokeswoman for the FDA.