The inquiry focused on Synthes’ disclosure of the financial interests of certain investigators involved in the clinical trials for the artificial spinal discs, ProDisc-L and ProDisc-C, which were approved by the US Food and Drug Administration (FDA) in August 2006 and December 2007, respectively.
Patient safety and the effectiveness of the ProDisc products were not issues in the inquiry. The FDA was advised of the results of the New Jersey inquiry and has not changed its conclusions that the ProDisc clinical studies are scientifically valid and that the ProDisc products are safe and effective.
Collaborations between physicians and the medical device industry have been important in the development of new and innovative clinical solutions. The FDA expressly permits clinical investigators to have financial interests in a product or company. The FDA requires, however, that clinical investigators disclose their relevant financial relationships to the company sponsoring a study and that the company report these financial disclosures to the FDA. It is important to note that FDA-approved clinical trials are specifically designed to eliminate or minimize the potential for investigator bias.
In the interest of a speedy resolution to the inquiry, Synthes voluntarily entered into the AVC without any admission of wrongdoing and has agreed to reimburse the State of New Jersey for the cost of the investigation in the amount of US$ 236,000. No fines or penalties were paid by Synthes.
