The New Jersey Attorney General has announced a settlement with Synthes, the medical device maker. The company had been accused of failing to disclose financial conflicts of interest among doctors researching its products. The Attorney General’s office is also investigating other similar conflicts in the medical device industry. At press time, subpoenas had been issued to five major device makers. Attorney General Anne Milgram said in a prepared statement:
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 these devices.
Under terms of the settlement, Synthes, the maker of the ProDisc artificial spinal disk, must disclose any future payments or investments held by doctors involved in researching its products. The company has agreed to make the information publicly available through its web site. Synthes has also agreed to stop paying doctors who are conducting clinical trials of its products with stock or stock options. The settlement requires the company to pay $236,000 to reimburse the attorney general’s office for its investigation. The State pursued the case under its consumer fraud laws.
Synthes, based in West Chester, Penn., is a unit of a Swiss company with the same name. The ProDisc was the subject of an article in The New York Times in 2008 about surgeons who had conducted the clinical studies leading to the device’s approval by the FDA. It was revealed in a lawsuit that was settled in 2007 that doctors at about half of the 17 research centers involved stood to profit if the ProDisc was successful.
In its subsequent investigation, New Jersey concluded that a majority of the doctors had significant investments in the products, but that Synthes failed to disclose the conflicts to the FDA. In a letter sent to the FDA and members of Congress, Attorney General Milgram criticized the agency for doing “nothing to regulate these conflicts,” despite what she described as an obvious lack of disclosure from the researchers, including some forms that were signed and dated but otherwise left blank. The Attorney General called on the FDA to increase its oversight and develop new regulations requiring companies to disclose conflicts of interest to the public.
Source: New York Times
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