Anne Milgram, New Jersey’s attorney general, appealed to the US Food and Drug Administration (FDA) after settling a case with Synthes, which gained pre-market approval from the agency “even when the financial conflict disclosures were plainly inadequate”.
The settlement with Synthes requires the company to disclose any future payments to, or company stock held by, physicians conducting its clinical trials.
In addition the company must pay physicians “fair market value compensation”, which cannot be done in company shares, and disclose all financial interests directly to health care facilities serving as clinical trial sites.
This has been hailed by Milgram as a template for the entire industry, which would stop the practices that, in the NJ’s attorney general’s opinion, is “simply wrong”.
Milgram added: “It is outrageous that doctors who are testing and, in many cases, recommending the use of certain high-risk medical devices are being compensated with stock in the very companies that make the devices.
“All patients – but especially those considering high-risk devices such as spinal disc replacements -- deserve honest, objective clinical trial information about the products available.We cannot allow financial conflicts of-interest to infect the clinical trial process. It is a betrayal of the public trust, and has the potential to jeopardise patient well-being.”
“FDA did nothing to regulate these conflicts”
The State of New Jersey launched an investigation into the financial conflicts of interests of the investigators participating in the clinical trials for Synthes in February 2008.
During the investigation it was revealed that the majority of physicians working on the clinical trial had significant investments in the product being tested, which would be worthless if it failed to gain regulatory approval.
Synthes failed to adequately disclose these conflicts of interest, which Milgram believes “should have been obvious from even a cursory review of its FDA submissions”.
Consequently Milgram has written to Joshua Sharfstein, then acting commissioner at the FDA, calling on the agency to adopt the agreement with Synthes as part of “best practices” for the industry.