|Public Statement of Chairman Robert Pitofsky and
Commissioner Mozelle W. Thompson
LANE LABS-USA, INC.
We appreciate the concerns raised by our colleague, Commissioner Swindle, regarding an order provision that allows defendant Lane Labs-USA, Inc., to pay $450,000 to provide shark cartilage for the National Cancer Institutes ("NCI") clinical trial to determine whether shark cartilage is effective in treating cancer. When NCI undertakes a clinical trial, the government funds the study after extensive review but does not typically fund acquisition of the product. In our view, it is highly unusual -- and likely to remain the exception -- to direct money to help fund clinical trials. Given the importance of evaluating shark cartilage as a therapy, we think the public interest is best served by the approach taken here.