ProDisc maker settles conflict of interest allegations
The Synthes company makes an artificial device, the ProDisc, which is surgically implanted between spinal vertebrae in a high-risk, expensive procedure that remains controversial. The company did not disclose for several years that the very doctors who were recommending use of the device were being compensated with shares in the company. In a negotiated settlement with the New Jersey Attorney General, the company agreed to pay $236,000.00 to the State for the cost of its investigation and to disclose all financial arrangements with medical "researchers." It also agreed to stop paying with stock or stock options doctors who conduct clinical trials of its products.
A 2008 article in the New York Times claimed that doctors at about half of the 17 research centers involved in testing the ProDisc would profit financially by the company's success. New Jersey subsequently confirmed that a majority of the doctors had significant investments in the company, but that Synthes had not disclosed this conflict to the F.D.A. The New Jersey Attorney General pointed out that Bush Administration-era officials at the FDA had not even investigated when some of the financial disclosure documents required by the FDA in the device-approval process were signed and dated but left blank.